Trial Outcomes & Findings for Remifentanil and Glycemic Response in Cardiac Surgery (NCT NCT02349152)
NCT ID: NCT02349152
Last Updated: 2020-04-21
Results Overview
Percentage of patients with two or more intraoperative blood glucose levels greater than 180 mg/dl. Percentage in both groups will be estimated, then the difference in this statistic will form the primary outcome measure of this study. (Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
116 participants
Primary outcome timeframe
Intraoperative period
Results posted on
2020-04-21
Participant Flow
The first subject was recruited 01-06-2016. The final subject was recruited 12-28-2016. All enrolled subjects were recruited at Presbyterian Hospital in Pittsburgh, Pennsylvania.
No pre-assignment necessary for enrollment
Participant milestones
| Measure |
Remifentanil Group
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
56
|
|
Overall Study
COMPLETED
|
54
|
52
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 years
n=54 Participants
|
71.0 years
n=52 Participants
|
70.5 years
n=106 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=54 Participants
|
14 Participants
n=52 Participants
|
33 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=54 Participants
|
38 Participants
n=52 Participants
|
73 Participants
n=106 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
54 participants
n=54 Participants
|
52 participants
n=52 Participants
|
106 participants
n=106 Participants
|
PRIMARY outcome
Timeframe: Intraoperative periodPercentage of patients with two or more intraoperative blood glucose levels greater than 180 mg/dl. Percentage in both groups will be estimated, then the difference in this statistic will form the primary outcome measure of this study. (Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016)
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Blood Glucose Values (More Than One ) > 180 mg%
|
17 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Intraoperative period; Induction to end of surgeryAverage dose of insulin (Units/ml) calculated for each group in the intraoperative period
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Insulin Requirement
|
2.9 Units/ml
Interval 0.0 to 35.1
|
8.1 Units/ml
Interval 0.0 to 46.7
|
SECONDARY outcome
Timeframe: Intraoperative period, Induction to end of surgeryBlood glucose values that exceed 180 mg% will be counted
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Number of Blood Glucose Values > 180 mg%
|
1.2 number of glucose values >180mg%
Interval 0.0 to 7.0
|
2 number of glucose values >180mg%
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Intraoperative period; Induction to end of surgeryBlood glucose measured every hour
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl)
Mean Introperative Blood Glucose
|
141 Mg/dL
Interval 84.0 to 292.0
|
156 Mg/dL
Interval 68.0 to 348.0
|
|
Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl)
Peak Intraoperative Blood Glucose
|
178 Mg/dL
Interval 110.0 to 292.0
|
205 Mg/dL
Interval 133.0 to 348.0
|
|
Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl)
Lowest Intraoperative Blood Glucose
|
117 Mg/dL
Interval 84.0 to 195.0
|
120 Mg/dL
Interval 68.0 to 178.0
|
SECONDARY outcome
Timeframe: From ICU Admission (After Surgery) Until 24 hours postoperativelyMean and peak blood glucose levels postoperatively
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Postoperative Blood Glucose
Mean Postoperative Blood Glucose
|
139 mg/dl
Interval 62.0 to 309.0
|
139 mg/dl
Interval 70.0 to 270.0
|
|
Postoperative Blood Glucose
Peak Postoperative Blood Glucose
|
185 mg/dl
Interval 136.0 to 309.0
|
175 mg/dl
Interval 127.0 to 270.0
|
SECONDARY outcome
Timeframe: From ICU Admission (After Surgery) Until 24 hours postoperativelyTotal units of regular insulin required post-operatively
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Total Postoperative Regular Insulin
|
28.1 International Units
Interval 0.0 to 196.0
|
23.5 International Units
Interval 0.0 to 158.0
|
SECONDARY outcome
Timeframe: induction of anesthesia till systemic heparinization before cardiopulmonary bypassPopulation: Resources not available to analyze
Blood pressure (systolic, diastolic and mean), Heart rate every 5 minutes from induction of anesthesia till systemic heparinization before cardiopulmonary bypass
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Perioperative period (Intraoperatively and 8 hours postoperatively)Serum cortisol levels (measured as µg/dl) taken at: Prebypass, cardiopulmonary bypass (2 samples: at start of bypass and end of bypass), postbypass, ICU 8 hours postoperative period
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Stress Hormone Levels-Cortisol (µg/dl)
Serum Cortisol Prebypass
|
12 µg/dl
Interval 2.0 to 21.0
|
12 µg/dl
Interval 3.0 to 26.0
|
|
Stress Hormone Levels-Cortisol (µg/dl)
Serum Cortisol 30 Minute After Start of CPB
|
6.0 µg/dl
Interval 1.0 to 19.0
|
24.5 µg/dl
Interval 7.0 to 43.0
|
|
Stress Hormone Levels-Cortisol (µg/dl)
Serum Cortisol End of CPB
|
5.0 µg/dl
Interval 1.0 to 15.0
|
29.0 µg/dl
Interval 6.0 to 52.0
|
|
Stress Hormone Levels-Cortisol (µg/dl)
Serum Cortisol End of Surgery
|
8.5 µg/dl
Interval 2.0 to 27.0
|
28.0 µg/dl
Interval 7.0 to 56.0
|
|
Stress Hormone Levels-Cortisol (µg/dl)
Serum Cortisol Postoperative (8 Hours)
|
36.0 µg/dl
Interval 14.0 to 81.0
|
45.0 µg/dl
Interval 8.0 to 80.0
|
SECONDARY outcome
Timeframe: Perioperative period (Intraoperatively and 8 hours postoperatively)Inflammatory mediator levels, Interleukin-1b (IL-1b), Interleukin 6 (IL-6) and Tumor Necrosis Factor Alpha (TNFa) (all measured in pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples:30 min start of bypass (CPB-30) and end of bypass (CPB-END), postbypass, ICU 8 hours postoperative period
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
IL-1b Pre-bypass
|
1.2 pg/ml
Interval 0.9 to 9.1
|
1.2 pg/ml
Interval 1.0 to 3.1
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
IL-1b CPB-30
|
1.1 pg/ml
Interval 1.0 to 6.3
|
1.1 pg/ml
Interval 0.9 to 3.0
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
IL-1b CPB-END
|
1.2 pg/ml
Interval 0.9 to 5.7
|
1.2 pg/ml
Interval 0.9 to 2.8
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
IL-1b 8-HR
|
1.2 pg/ml
Interval 0.9 to 6.1
|
1.2 pg/ml
Interval 0.7 to 3.8
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
IL-6 Pre-bypass
|
2.8 pg/ml
Interval 1.0 to 329.0
|
2.6 pg/ml
Interval 0.8 to 38.5
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
IL-6 CPB-30
|
7.4 pg/ml
Interval 1.3 to 58.7
|
10.3 pg/ml
Interval 1.8 to 148.0
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
IL-6 CPB-END
|
77.2 pg/ml
Interval 5.3 to 1499.0
|
78.3 pg/ml
Interval 6.6 to 3478.0
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
IL-6 post-bypass
|
136 pg/ml
Interval 17.2 to 2504.0
|
90.9 pg/ml
Interval 13.2 to 8564.0
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
TNFa CPB-30
|
14.4 pg/ml
Interval 5.5 to 49.7
|
12.6 pg/ml
Interval 4.1 to 26.6
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
TNFa CPB-END
|
18.2 pg/ml
Interval 6.0 to 51.9
|
14.8 pg/ml
Interval 3.6 to 56.5
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
TNFa post-bypass
|
24.0 pg/ml
Interval 5.3 to 136.0
|
17.2 pg/ml
Interval 4.5 to 52.2
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
TNFa 8HR
|
15.4 pg/ml
Interval 1.1 to 41.8
|
11.2 pg/ml
Interval 4.5 to 44.7
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
IL-1b post-bypass
|
1.1 pg/ml
Interval 0.9 to 7.5
|
1.3 pg/ml
Interval 0.9 to 3.4
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
IL-6 8HR
|
93.6 pg/ml
Interval 5.1 to 2473.0
|
92.3 pg/ml
Interval 16.7 to 12128.0
|
|
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
TNFa-Pre-bypass
|
11.7 pg/ml
Interval 2.1 to 29.7
|
10.4 pg/ml
Interval 3.1 to 24.6
|
SECONDARY outcome
Timeframe: Perioperative period (Intraoperatively and 8 hours postoperatively)Adreno-corticotrophic hormone (ACTH), Growth Hormone (GH) and Glucagon (measured as pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples: 30 mins after start of bypass (CPB 30) and end of bypass (CPB END), post-bypass and ICU 8 hours postoperative period
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
ACTH pre-bypass
|
7.4 pg/ml
Interval 1.6 to 52.1
|
7.4 pg/ml
Interval 2.1 to 36.6
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
GH-Pre-bypass
|
495 pg/ml
Interval 3.2 to 74329.0
|
872 pg/ml
Interval 20.0 to 14106.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
GH-CPB-30
|
826 pg/ml
Interval 26.0 to 88613.0
|
3202 pg/ml
Interval 355.0 to 192177.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
GH-CPB-END
|
947 pg/ml
Interval 16.7 to 252584.0
|
2545 pg/ml
Interval 117.0 to 169125.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
GH-post-bypass
|
37364 pg/ml
Interval 138.0 to 257569.0
|
4461 pg/ml
Interval 180.0 to 185442.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
GH-8HR
|
3658 pg/ml
Interval 217.0 to 213721.0
|
2696 pg/ml
Interval 145.0 to 208259.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
Glucagon pre-bypass
|
229 pg/ml
Interval 4.6 to 2715.0
|
192 pg/ml
Interval 5.1 to 2242.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
Glucagon CPB-30
|
259 pg/ml
Interval 4.8 to 1366.0
|
338 pg/ml
Interval 6.2 to 2635.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
Glucagon CPB-End
|
401 pg/ml
Interval 5.7 to 3226.0
|
481 pg/ml
Interval 8.2 to 3979.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
Glucagon post-bypass
|
315 pg/ml
Interval 5.0 to 2557.0
|
408 pg/ml
Interval 6.8 to 2691.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
Glucagon 8-HR
|
570 pg/ml
Interval 7.5 to 2019.0
|
459 pg/ml
Interval 5.0 to 4002.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
ACTH CPB-30
|
4.4 pg/ml
Interval 1.8 to 27.4
|
57.8 pg/ml
Interval 2.2 to 691.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
ACTH CPB-END
|
4.4 pg/ml
Interval 1.8 to 382.0
|
30.7 pg/ml
Interval 2.9 to 1167.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
ACTH post-bypass
|
8.0 pg/ml
Interval 1.6 to 179.0
|
49.1 pg/ml
Interval 2.7 to 6719.0
|
|
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
ACTH 8-hr
|
77.0 pg/ml
Interval 3.0 to 1022.0
|
41.3 pg/ml
Interval 1.8 to 3351.0
|
SECONDARY outcome
Timeframe: 30 day outcomesPostoperative outcomes collected from the Society of Thoracic Surgery (STS) database. 30 day Mortality (outcome 1) and 30 day Readmission (outcome 2) cerebral vascular accident(outcome 3), prolonged mechanical ventilation (outcome 4), renal failure (outcome 5), atrial fibrillation (outcome 6), cardiac arrest (outcome 7)
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Society of Thoracic Surgery Patient Outcomes
30 day Mortality
|
1 participants
|
6 participants
|
|
Society of Thoracic Surgery Patient Outcomes
30 day Readmission
|
3 participants
|
10 participants
|
|
Society of Thoracic Surgery Patient Outcomes
Cerebral Vascular Accident
|
0 participants
|
2 participants
|
|
Society of Thoracic Surgery Patient Outcomes
Prolonged mechanical ventilation
|
8 participants
|
8 participants
|
|
Society of Thoracic Surgery Patient Outcomes
renal failure
|
3 participants
|
3 participants
|
|
Society of Thoracic Surgery Patient Outcomes
atrial fibrillation
|
24 participants
|
18 participants
|
|
Society of Thoracic Surgery Patient Outcomes
cardiac arrest
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Every day 6 hour for 48 hours postoperative periodPopulation: This is a mixed model analysis to account for missing VAS values
Pain scores; Every day 6 hour for 48 hours postoperative period
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Postoperative Pain
Hours 0-6
|
6.63 score on a scale
Standard Deviation 1.66
|
7.18 score on a scale
Standard Deviation 2.37
|
|
Postoperative Pain
Hrs 7-12
|
6.53 score on a scale
Standard Deviation 2.23
|
6.09 score on a scale
Standard Deviation 2.19
|
|
Postoperative Pain
Hrs 13-18
|
6.59 score on a scale
Standard Deviation 2.07
|
5.18 score on a scale
Standard Deviation 2.76
|
|
Postoperative Pain
Hrs 19-24
|
5.88 score on a scale
Standard Deviation 2.28
|
5.73 score on a scale
Standard Deviation 2.38
|
|
Postoperative Pain
Hrs 25-30
|
5.94 score on a scale
Standard Deviation 5.94
|
5.65 score on a scale
Standard Deviation 2.25
|
|
Postoperative Pain
Hrs 31-36
|
5.89 score on a scale
Standard Deviation 2.31
|
5.94 score on a scale
Standard Deviation 2.44
|
|
Postoperative Pain
Hrs 37-42
|
5.57 score on a scale
Standard Deviation 2.35
|
5.18 score on a scale
Standard Deviation 2.70
|
|
Postoperative Pain
Hrs 43-48
|
5.08 score on a scale
Standard Deviation 2.74
|
5.10 score on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: Immediate postoperative period until 30 days post-operativelyTime to extubation after completion of surgery in the operating room and intensive care unit
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Emergence From Anesthesia
|
3 Hours
Interval 0.0 to 141.0
|
2.5 Hours
Interval 0.0 to 258.0
|
SECONDARY outcome
Timeframe: 96 hours postoperativelyVon frey hair objective testing
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Wound Hyperalgesia
Preop pain threshold
|
3.24 g/mm^2
Standard Deviation 0.94
|
3.30 g/mm^2
Standard Deviation 1.08
|
|
Wound Hyperalgesia
48 Hr pain threshold
|
3.71 g/mm^2
Standard Deviation 1.00
|
3.83 g/mm^2
Standard Deviation 1.28
|
|
Wound Hyperalgesia
96 hr pain threshold
|
3.60 g/mm^2
Standard Deviation 1.08
|
3.72 g/mm^2
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: 1, 3, 6 and 12 months after discharge from the hospitalTelephonic call Numeric pain scale; Scale is 0-10, with 10 being the highest pain.
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Development of Chronic Pain
S-LANSS 12 mo
|
0 score on a scale
Interval 0.0 to 3.0
|
0 score on a scale
Interval 0.0 to 3.0
|
|
Development of Chronic Pain
S-LANSS 1 mo
|
1 score on a scale
Interval 0.0 to 8.0
|
3 score on a scale
Interval 0.0 to 8.0
|
|
Development of Chronic Pain
S-LANSS 3 mo
|
0 score on a scale
Interval 0.0 to 8.0
|
0 score on a scale
Interval 0.0 to 6.0
|
|
Development of Chronic Pain
S-LANSS 6 mo
|
0 score on a scale
Interval 0.0 to 3.0
|
0 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: From the start of induction till 24 hours postoperativelyCoefficient of variation in blood glucose levels. Denotes how large the fluctuations in blood glucose are. Higher numbers indicate increased variation.
Outcome measures
| Measure |
Remifentanil Group
n=54 Participants
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 Participants
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Glycemic Variability
|
0.2 Percent of Mean Glucose Level
Interval 0.1 to 0.3
|
0.2 Percent of Mean Glucose Level
Interval 0.1 to 0.4
|
Adverse Events
Remifentanil Group
Serious events: 1 serious events
Other events: 28 other events
Deaths: 3 deaths
Fentanyl Group
Serious events: 5 serious events
Other events: 27 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Remifentanil Group
n=54 participants at risk
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 participants at risk
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/54
|
1.9%
1/52
|
|
Cardiac disorders
Pericardial effusion/tamponade
|
0.00%
0/54
|
1.9%
1/52
|
|
Nervous system disorders
Stroke
|
1.9%
1/54
|
0.00%
0/52
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/54
|
5.8%
3/52
|
Other adverse events
| Measure |
Remifentanil Group
n=54 participants at risk
Half of subjects enrolled will be randomized to the remifentanil group
Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
|
Fentanyl Group
n=52 participants at risk
Half of subjects enrolled will be randomized to the fentanyl group
Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
|
|---|---|---|
|
Surgical and medical procedures
Any postoperative complication
|
51.9%
28/54
|
51.9%
27/52
|
|
Surgical and medical procedures
Sepsis
|
7.4%
4/54
|
7.7%
4/52
|
|
Vascular disorders
Cerebrovascular Accident
|
0.00%
0/54
|
3.8%
2/52
|
|
Vascular disorders
Transient Ischemic Attacks
|
1.9%
1/54
|
0.00%
0/52
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged Mechanical Ventilation (>72 hours)
|
14.8%
8/54
|
15.4%
8/52
|
|
Respiratory, thoracic and mediastinal disorders
Reintubation
|
9.3%
5/54
|
13.5%
7/52
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
7.4%
4/54
|
5.8%
3/52
|
|
Vascular disorders
Pulmonary Thromboembolism
|
0.00%
0/54
|
0.00%
0/52
|
|
Vascular disorders
Venous Thromboembolism
|
1.9%
1/54
|
0.00%
0/52
|
|
Renal and urinary disorders
Renal Failure
|
5.6%
3/54
|
5.8%
3/52
|
|
Renal and urinary disorders
Dialysis
|
5.6%
3/54
|
5.8%
3/52
|
|
Surgical and medical procedures
Rhythm Requiring Permanent Pacemaker Insertion
|
3.7%
2/54
|
0.00%
0/52
|
|
Surgical and medical procedures
Rhythm Requiring Permanent Pacemaker/ACID
|
0.00%
0/54
|
3.8%
2/52
|
|
Cardiac disorders
Cardiac Arrest
|
5.6%
3/54
|
5.8%
3/52
|
|
General disorders
Multisystem Organ Failure
|
5.6%
3/54
|
3.8%
2/52
|
|
General disorders
Readmission within 30 days
|
3.7%
2/54
|
9.6%
5/52
|
Additional Information
Dr. Kathirvel Subramaniam, MD, MPH
University of Pittsburgh
Phone: 412-647-5635
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place