Trial Outcomes & Findings for Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD) (NCT NCT01555554)
NCT ID: NCT01555554
Last Updated: 2026-07-02
Results Overview
Measured using patient medical records
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
Truncated at 30 days after admission to ICU
Results posted on
2026-07-02
Participant Flow
A total of 14,504 patients were screened for eligibility with 126 providing written consent and undergoing PDS assessment and 83 subjects potentially meeting inclusion criteria. Of those 83, 24 subjects were not found to not meet inclusion criteria due to postponement in surgery, change in condition, or due to the stress associated with talking about the trauma. Ultimately, only 59 participants met all inclusion criteria and were enrolled out of the originally planned 110 subjects anticipated.
Participant milestones
| Measure |
Propranolol Hydrochloride
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Propranolol Hydrochloride
n=29 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=30 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 6.11 • n=20 Participants
|
58.3 years
STANDARD_DEVIATION 10.36 • n=20 Participants
|
60.75 years
STANDARD_DEVIATION 8.75 • n=40 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
47 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Non-white or hispanic
|
6 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=20 Participants
|
30 participants
n=20 Participants
|
59 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Truncated at 30 days after admission to ICUMeasured using patient medical records
Outcome measures
| Measure |
Propranolol Hydrochloride
n=29 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=30 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
ICU Length of Stay
|
0.79 days
Standard Deviation 2.1
|
1.07 days
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Truncated at 30 days after admission to ICUMeasured using patient medical records
Outcome measures
| Measure |
Propranolol Hydrochloride
n=29 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=30 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Hospital Length of Stay
|
3.38 days
Standard Deviation 3.22
|
4 days
Standard Deviation 3.42
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 weekMeasured using Confusion Assessment Method (CAM-CAM-ICU)
Outcome measures
| Measure |
Propranolol Hydrochloride
n=29 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=30 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Postoperative Delirium
|
4 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 weekMeasured using Serum Creatinine laboratory values
Outcome measures
| Measure |
Propranolol Hydrochloride
n=27 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=27 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Postoperative Renal Dysfunction
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 weekMeasured using patient medical records
Outcome measures
| Measure |
Propranolol Hydrochloride
n=27 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=27 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Perioperative Complications
|
4 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPain intensity was measured using a Numerical Rating Scale (NRS). The range of the NRS is 0 and 10, where zero represents no pain at all and 10 represents the worst pain ever possible.
Outcome measures
| Measure |
Propranolol Hydrochloride
n=2 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=3 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Pain Intensity
|
0.0 score on a scale
Standard Deviation 0.0
|
0.3 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The 12 month survey response rate was low.
Measured using the Numerical Rating Scale (NRS). The range of the NRS is 0 and 10, where zero represents no pain at all and 10 represents the worst pain ever possible.
Outcome measures
| Measure |
Propranolol Hydrochloride
n=2 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=3 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Pain Unpleasantness
|
4.5 score on a scale
Standard Deviation 3.5
|
2.33 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Participants will be followed from preoperative baseline to 1 year postoperativeMeasured using patient medical records.
Outcome measures
| Measure |
Propranolol Hydrochloride
n=10 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=9 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Perioperative Opioids Use
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 weekMeasured using patient medical records
Outcome measures
| Measure |
Propranolol Hydrochloride
n=29 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=30 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Required Mechanical Ventilation
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe Posttraumatic Diagnostic Scale (PDS) Scale includes a PTSD Symptoms Severity Score ranging from 0 to 51, with higher scores indicating more severe depression.
Outcome measures
| Measure |
Propranolol Hydrochloride
n=14 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=15 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Change in Posttraumatic Diagnostic Scale (PDS) PTSD Symptoms Severity Score
|
-7.1 score on a scale
Standard Deviation 11.3
|
2.1 score on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Participants will be followed from preoperative baseline to 1 year postoperativeThe Mental Component Summary (MCS) score is derived from the Short Form-36 Questionnaire (SF-36), a validated measure of health-related quality of life. Scores range from 0 to 100, with higher scores indicating better mental health and lower scores indicating worse mental health.
Outcome measures
| Measure |
Propranolol Hydrochloride
n=14 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=13 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Change in Mental Component Summary (MCS) Scores From the Short Form-36 Questionnaire (SF-36)
|
4.5 Score on a scale
Standard Deviation 9.3
|
-4.7 Score on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Participants will be followed from preoperative baseline to 1 year postoperativeThe Physical Component Summary (PCS) score is derived from the Short Form-36 Questionnaire (SF-36), a validated measure of health-related quality of life. Scores range from 0 to 100, with higher scores indicating better physical health and lower scores indicating worse physical health.
Outcome measures
| Measure |
Propranolol Hydrochloride
n=14 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=13 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Change in Physical Component Summary (PCS) Scores From the Short Form-36 Questionnaire (SF-36)
|
6.9 Score on a scale
Standard Deviation 9.0
|
2.7 Score on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Participants will be followed from preoperative baseline to 1 year postoperativeThe Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire assessing sleep quality. Total scores range from 0 to 21, with higher scores indicating worse sleep quality and lower scores indicating better sleep quality
Outcome measures
| Measure |
Propranolol Hydrochloride
n=14 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=15 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI) Score
|
0.5 Score on a scale
Standard Deviation 3.6
|
-2.2 Score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Participants will be followed from preoperative baseline to 1 year postoperativeThe Beck Depression Inventory (BDI) is a validated self-report measure of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms (worse outcome) and lower scores indicating fewer or minimal symptoms (better outcome).
Outcome measures
| Measure |
Propranolol Hydrochloride
n=14 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=15 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Change in Beck Depression Inventory (BDI) Score
|
-8.6 Score on a scale
Standard Deviation 9.3
|
0.6 Score on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Participants will be followed from preoperative baseline to 1 year postoperativePopulation: There were 5 participants with data available for this outcome measure at 1 year.
The Mini-Mental State Examination (MMSE) is a widely used screening tool for cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function and lower scores indicating greater cognitive impairment.
Outcome measures
| Measure |
Propranolol Hydrochloride
n=2 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=3 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Postoperative Neurocognitive Dysfunction Score
|
27 score on a scale
Standard Deviation 1.41
|
29.33 score on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Participants will be followed from preoperative baseline to 1 year postoperativeMeasured using patient medical records
Outcome measures
| Measure |
Propranolol Hydrochloride
n=29 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=30 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
30-day, 3-month, and 1-year Mortality
30 days
|
0 Participants
|
0 Participants
|
|
30-day, 3-month, and 1-year Mortality
3 months
|
0 Participants
|
0 Participants
|
|
30-day, 3-month, and 1-year Mortality
1 year
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Participants will be followed to 1 year postoperativePopulation: There were 5 missing values for this measure 2 from the Propranolol group and 3 from the Placebo group.
Measured using patient medical records - Composite outcome measure that included, delirium, stroke, myocardial infarction, acute kidney injury, new atrial fibrilation, infection, or congestive heart failure between the surgery and 1-yr.
Outcome measures
| Measure |
Propranolol Hydrochloride
n=27 Participants
Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
|
Placebo Group
n=27 Participants
Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
|
|---|---|---|
|
Postoperative Complications
|
5 Participants
|
13 Participants
|
Adverse Events
Propranolol Hydrochloride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marek Brzezinski, MD, PhD
University of California, San Francisco
Phone: 415-221-4810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place