Trial Outcomes & Findings for Olanzapine for Nausea After Surgery (NCT NCT02755116)
NCT ID: NCT02755116
Last Updated: 2020-07-27
Results Overview
Number of participants with post-discharge nausea and/or vomiting
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
in 24 hours after discharge
Results posted on
2020-07-27
Participant Flow
180 patients consented, 36 excluded prior to study drug administration and 144 patients were randomized and enrolled.
Participant milestones
| Measure |
Olanzapine
10-mg dose of olanzapine by mouth prior to anesthetic induction
|
Placebo
placebo by mouth prior to anesthetic induction
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
70
|
|
Overall Study
COMPLETED
|
71
|
69
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Olanzapine
10-mg dose of olanzapine by mouth prior to anesthetic induction
|
Placebo
placebo by mouth prior to anesthetic induction
|
|---|---|---|
|
Overall Study
surgery converted to open, pt admitted
|
3
|
1
|
Baseline Characteristics
Olanzapine for Nausea After Surgery
Baseline characteristics by cohort
| Measure |
Olanzapine
n=71 Participants
10mg of olanzapine by mouth prior to anesthetic induction
|
Placebo
n=69 Participants
placebo by mouth prior to anesthetic induction
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 7 • n=5 Participants
|
37 years
STANDARD_DEVIATION 7 • n=7 Participants
|
37 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status
I
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status
II
|
49 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status
III
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.8 kg/m^2
STANDARD_DEVIATION 6.3 • n=5 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 5.9 • n=7 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
History of postoperative nausea/vomiting
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Motion Sickness
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Nonsmoker
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Number of Risk Factors
2
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Number of Risk Factors
3
|
43 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Number of Risk Factors
4
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Surgery type
Laparoscopic gynecologic
|
54 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Surgery type
Hysteroscopy
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Surgery type
Vaginal
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Surgery type
Plastics
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: in 24 hours after dischargeNumber of participants with post-discharge nausea and/or vomiting
Outcome measures
| Measure |
Olanzapine
n=71 Participants
10-mg dose of olanzapine by mouth prior to anesthetic induction
|
Placebo
n=69 Participants
placebo by mouth prior to anesthetic induction
|
|---|---|---|
|
Number of Participants With Nausea and/or Vomiting
|
10 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: in 24 hours after dischargeNumber of participants with severe postdischarge nausea, defined as numerical rating scale score greater than 3. (11-point numerical rating scale from 0-10, higher score indicating worse nausea)
Outcome measures
| Measure |
Olanzapine
n=71 Participants
10-mg dose of olanzapine by mouth prior to anesthetic induction
|
Placebo
n=69 Participants
placebo by mouth prior to anesthetic induction
|
|---|---|---|
|
Number of Participants With Severe Nausea
|
4 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: in 24 hours after dischargeNumber of participants with post discharge vomiting
Outcome measures
| Measure |
Olanzapine
n=71 Participants
10-mg dose of olanzapine by mouth prior to anesthetic induction
|
Placebo
n=69 Participants
placebo by mouth prior to anesthetic induction
|
|---|---|---|
|
Number of Participants With Postdischarge Vomiting
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: first 24 hours post-opNumber of participants with postoperative nausea and/or vomiting (PONV) in first 24 hours
Outcome measures
| Measure |
Olanzapine
n=71 Participants
10-mg dose of olanzapine by mouth prior to anesthetic induction
|
Placebo
n=69 Participants
placebo by mouth prior to anesthetic induction
|
|---|---|---|
|
Number of Participants With PONV
|
22 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: first 24 hours post-opNumber of participants with severe PONV in first 24 hours after post-op.defined as numerical rating scale score greater than 3. (11-point numerical rating scale from 0-10, higher score indicating worse nausea)
Outcome measures
| Measure |
Olanzapine
n=71 Participants
10-mg dose of olanzapine by mouth prior to anesthetic induction
|
Placebo
n=69 Participants
placebo by mouth prior to anesthetic induction
|
|---|---|---|
|
Number of Participants With Severe PONV
|
12 Participants
|
26 Participants
|
Adverse Events
Olanzapine
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Olanzapine
n=71 participants at risk
10-mg dose of olanzapine by mouth prior to anesthetic induction
|
Placebo
n=69 participants at risk
placebo by mouth prior to anesthetic induction
|
|---|---|---|
|
Nervous system disorders
Dizziness or lightheadedness
|
29.6%
21/71 • 24 hours after discharge
|
39.1%
27/69 • 24 hours after discharge
|
|
Eye disorders
Visual disturbances
|
2.8%
2/71 • 24 hours after discharge
|
0.00%
0/69 • 24 hours after discharge
|
|
Renal and urinary disorders
Urinary retention
|
1.4%
1/71 • 24 hours after discharge
|
0.00%
0/69 • 24 hours after discharge
|
Additional Information
Dr. Jaime B. Hyman
Icahn School of Medicine at Mount Sinai
Phone: 212-241-7473
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place