Trial Outcomes & Findings for The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery (NCT NCT05676294)
NCT ID: NCT05676294
Last Updated: 2026-07-16
Results Overview
Quality of Recovery-40 (QoR-40) survey is a 40-item questionnaire that provides a global score across five dimensions: patient support, comfort, emotions, physical independence, and pain. The survey is scored on a 5-point Likert scale: for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
COMPLETED
PHASE2
398 participants
post-operative day 1
2026-07-16
Participant Flow
Participants were recruited to the trial from June 26, 2023 through December 6, 2025 at Yale New Haven Hospital in New Haven, CT and Shoreline Surgery Center in Guilford, CT
398 patients were consented to participate in the trial. Twelve patients were withdrawn from the trial prior to randomization including: patient withdrew consent (n=4), surgery rescheduled (n=3), investigator unable to randomize (n=2), patient enrolled in a conflicting study (n=1), surgery cancelled (n=1), patient admission planned (n=1). Two patients were withdrawn after randomization but prior to receiving study medication including: vasovagal syncope (n = 1), patient withdrew consent (n = 1).
Participant milestones
| Measure |
Olanzapine
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Overall Study
STARTED
|
191
|
193
|
|
Overall Study
Postoperative Day 1 Survey Completion (Primary Outcome)
|
190
|
192
|
|
Overall Study
COMPLETED
|
189
|
191
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Olanzapine
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery
Baseline characteristics by cohort
| Measure |
Olanzapine
n=191 Participants
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
n=193 Participants
placebo oral tablet once prior to surgery
|
Total
n=384 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 Years
STANDARD_DEVIATION 8 • n=9 Participants
|
38 Years
STANDARD_DEVIATION 8 • n=27 Participants
|
38 Years
STANDARD_DEVIATION 8 • n=267 Participants
|
|
Sex: Female, Male
Female
|
191 Participants
n=9 Participants
|
193 Participants
n=27 Participants
|
384 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=9 Participants
|
33 Participants
n=27 Participants
|
51 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
167 Participants
n=9 Participants
|
151 Participants
n=27 Participants
|
318 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
154 Participants
n=9 Participants
|
145 Participants
n=27 Participants
|
299 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
15 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
32 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Race · Other/Unknown
|
22 Participants
n=9 Participants
|
31 Participants
n=27 Participants
|
53 Participants
n=267 Participants
|
|
Body Mass Index
|
29 kg/m^2
STANDARD_DEVIATION 7 • n=9 Participants
|
29 kg/m^2
STANDARD_DEVIATION 8 • n=27 Participants
|
29 kg/m^2
STANDARD_DEVIATION 8 • n=267 Participants
|
|
American Society of Anesthesiologists- Physical Status Classification (ASA-PS)
1
|
26 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
44 Participants
n=267 Participants
|
|
American Society of Anesthesiologists- Physical Status Classification (ASA-PS)
2
|
137 Participants
n=9 Participants
|
147 Participants
n=27 Participants
|
284 Participants
n=267 Participants
|
|
American Society of Anesthesiologists- Physical Status Classification (ASA-PS)
3
|
28 Participants
n=9 Participants
|
28 Participants
n=27 Participants
|
56 Participants
n=267 Participants
|
|
Surgery procedure type
Hysteroscopy
|
42 Participants
n=9 Participants
|
37 Participants
n=27 Participants
|
79 Participants
n=267 Participants
|
|
Surgery procedure type
Laparoscopic gynecologic
|
70 Participants
n=9 Participants
|
66 Participants
n=27 Participants
|
136 Participants
n=267 Participants
|
|
Surgery procedure type
Vaginal
|
16 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
38 Participants
n=267 Participants
|
|
Surgery procedure type
Breast
|
20 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
41 Participants
n=267 Participants
|
|
Surgery procedure type
Otolaryngology
|
28 Participants
n=9 Participants
|
30 Participants
n=27 Participants
|
58 Participants
n=267 Participants
|
|
Surgery procedure type
Other
|
15 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
32 Participants
n=267 Participants
|
|
Apfel score
2
|
77 Participants
n=9 Participants
|
58 Participants
n=27 Participants
|
135 Participants
n=267 Participants
|
|
Apfel score
3
|
83 Participants
n=9 Participants
|
91 Participants
n=27 Participants
|
174 Participants
n=267 Participants
|
|
Apfel score
4
|
31 Participants
n=9 Participants
|
44 Participants
n=27 Participants
|
75 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: post-operative day 1Population: Two participants were lost to follow-up for the postoperative day one survey (1 in the olanzapine group and 1 in the placebo group)
Quality of Recovery-40 (QoR-40) survey is a 40-item questionnaire that provides a global score across five dimensions: patient support, comfort, emotions, physical independence, and pain. The survey is scored on a 5-point Likert scale: for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Outcome measures
| Measure |
Olanzapine
n=190 Participants
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
n=192 Participants
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy
|
183 Scores on a scale
Interval 181.0 to 185.0
|
174 Scores on a scale
Interval 172.0 to 176.0
|
SECONDARY outcome
Timeframe: post-operative day 2Population: Two additional participants (four total) were lost to follow-up for the postoperative day 2 survey (2 in the olanzapine group and 2 in the placebo group).
Quality of Recovery-40 (QoR-40) survey is a 40-item questionnaire that provides a global score across five dimensions: patient support, comfort, emotions, physical independence, and pain. The survey is scored on a 5-point Likert scale: for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Outcome measures
| Measure |
Olanzapine
n=189 Participants
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
n=191 Participants
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy
|
185 Scores on a scale
Interval 183.0 to 187.0
|
180 Scores on a scale
Interval 178.0 to 182.0
|
SECONDARY outcome
Timeframe: post-operative day 1Nausea was assessed using a numerical rating scale from 0 to 10, where 0 indicated no nausea and 10 indicated the worst nausea imaginable. For this outcome measure, participants were classified as having any nausea if they reported a nausea score greater than 0 at any assessment during the specified time period.
Outcome measures
| Measure |
Olanzapine
n=191 Participants
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
n=193 Participants
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Participants With Any Nausea
|
52 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: post-operative day 2Nausea was assessed using a numerical rating scale from 0 to 10, where 0 indicated no nausea and 10 indicated the worst nausea imaginable. For this outcome measure, participants were classified as having any nausea if they reported a nausea score greater than 0 at any assessment during the specified time period.
Outcome measures
| Measure |
Olanzapine
n=191 Participants
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
n=193 Participants
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Participants With Any Nausea
|
38 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: up to 24 hours post dischargeSevere post-discharge nausea defined as any numerical rating \> 3 on a 0-10 scale during the 24 hours after discharge
Outcome measures
| Measure |
Olanzapine
n=191 Participants
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
n=193 Participants
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Number of Participants With Severe Post-discharge Nausea
|
15 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: From surgery end time to recovery room discharge, up to 23 hoursRecovery room length of stay in minutes
Outcome measures
| Measure |
Olanzapine
n=191 Participants
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
n=193 Participants
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Recovery Room Length of Stay
|
110 Minutes
Interval 84.0 to 148.0
|
114 Minutes
Interval 87.0 to 151.0
|
SECONDARY outcome
Timeframe: From surgery end time to recovery room discharge, up to 23 hoursRecovery room opioid consumption in morphine milligram equivalents
Outcome measures
| Measure |
Olanzapine
n=191 Participants
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
n=193 Participants
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Recovery Room Opioid Consumption
|
0 Morphine Miligram Equivalents
Interval 0.0 to 15.0
|
6 Morphine Miligram Equivalents
Interval 0.0 to 15.0
|
Adverse Events
Olanzapine
Placebo
Serious adverse events
| Measure |
Olanzapine
n=191 participants at risk
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
n=193 participants at risk
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Surgical and medical procedures
Urethral injury requiring return to operating room
|
0.00%
0/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.52%
1/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Surgical and medical procedures
Return to operating room for surgical bleeding
|
0.52%
1/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.52%
1/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Surgical and medical procedures
Severe postoperative nausea requiring hospital admission
|
0.00%
0/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.52%
1/193 • From administration of study medication until end of follow-up on postoperative day 2
|
Other adverse events
| Measure |
Olanzapine
n=191 participants at risk
olanzapine oral tablet, 5mg, once prior to surgery
|
Placebo
n=193 participants at risk
placebo oral tablet once prior to surgery
|
|---|---|---|
|
Surgical and medical procedures
Vasovagal syncope
|
0.00%
0/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.52%
1/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Eye disorders
Blurred vision
|
0.52%
1/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.00%
0/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.52%
1/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Surgical and medical procedures
Orthostatic hypotension
|
0.00%
0/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.52%
1/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Surgical and medical procedures
Nasal irritation and sneezing
|
0.52%
1/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.00%
0/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Surgical and medical procedures
Trace right lower extremity edema
|
0.52%
1/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.00%
0/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Surgical and medical procedures
Lightheadedness
|
0.00%
0/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.52%
1/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Surgical and medical procedures
Facial paresthesia
|
0.00%
0/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.52%
1/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Surgical and medical procedures
Dizziness
|
0.52%
1/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.00%
0/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Surgical and medical procedures
Hypotension
|
0.52%
1/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.00%
0/193 • From administration of study medication until end of follow-up on postoperative day 2
|
|
Surgical and medical procedures
Emergence delirium
|
0.00%
0/191 • From administration of study medication until end of follow-up on postoperative day 2
|
0.52%
1/193 • From administration of study medication until end of follow-up on postoperative day 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place