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Olanzapine for Nausea After Surgery

Olanzapine for the Treatment of Post-Discharge Nausea and Vomiting After Ambulatory Surgery

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02755116
Enrollment
180
Registered
2016-04-28
Start date
2016-04-30
Completion date
2019-09-05
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

Nausea, Vomiting

Brief summary

Ambulatory surgery is occurring with rapidly increasing frequency as surgical and anesthetic techniques have improved and pressure to reduce health-care costs has increased. While there are many benefits to recovering from surgery within the home, a significant disadvantage is the lack of rapid access to a healthcare provider when postoperative complications occur. Postoperative nausea and vomiting (PONV) are common after surgery and anesthesia, and recent studies have demonstrated a high incidence of post-discharge nausea and vomiting (PDNV) after ambulatory surgery, particularly in high-risk groups (female gender, age less than 50 years, history of PONV, opioid administration in the post-anesthesia care unit (PACU), and nausea in the PACU). Current practices known to reduce the risk of postoperative nausea and vomiting in the PACU, such as the avoidance of volatile anesthetics and the use of intraoperative ondansetron and steroids, have little effect on the risk of delayed PDNV. Novel strategies to prevent PDNV are needed. Orally administered olanzapine, which has been shown to decrease the incidence of chemotherapy-induced nausea and vomiting, demonstrates promise as a novel strategy for preventing PDNV. It has a long half-life, allowing for a single dose to be administered preoperatively. This study will evaluate whether there is a difference in the incidence and severity of PDNV between patients who receive oral olanzapine versus placebo prior to general anesthesia for ambulatory surgery.

Interventions

DRUGOlanzapine

10mg of olanzapine by mouth prior to anesthetic induction

DRUGPlacebo

placebo by mouth prior to anesthetic induction

Sponsors

Jaime B Hyman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Adults age ≥ 18 and ≤ 50 years old * Patient scheduled to undergo ambulatory surgery under general anesthesia * Willing and able to provide informed consent

Exclusion criteria

* Unable to swallow pills * Current use of typical or atypical anti-psychotic medications * History of allergy to olanzapine * Pregnancy/Lactation (subjects of child-bearing potential will have a urine pregnancy test performed the day of surgery) * History of QTc \> 450ms or torsades de pointes * Current use of antihypertensive medication * Diabetes Mellitus * Clinically significant cardiovascular disease defined as follows: 1. Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery. 2. History of serious ventricular arrhythmia (i.e.: ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled on anti-arrhythmic medication. 3. New York Heart Association (NYHA) Class II or higher congestive heart failure. * Postural hypotension or vasovagal syncope within 6 months of planned surgery. * Hypotension on day of surgery, defined as a systolic blood pressure \< 90mm Hg or a diastolic pressure \< 60mm Hg. * Seizure disorder * Clinically active prolactinoma * Hepatic disease * Poorly controlled diabetes * Pre-operative blood glucose \> 250 mg/dL * Narrow angle glaucoma * Parkinson's disease * Lewy body dementia

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Nausea and/or Vomitingin 24 hours after dischargeNumber of participants with post-discharge nausea and/or vomiting
Number of Participants With Severe Nauseain 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)

Secondary

MeasureTime frameDescription
Number of Participants With Postdischarge Vomitingin 24 hours after dischargeNumber of participants with post discharge vomiting
Number of Participants With PONVfirst 24 hours post-opNumber of participants with postoperative nausea and/or vomiting (PONV) in first 24 hours
Number of Participants With Severe PONVfirst 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)

Countries

United States

Participant flow

Recruitment details

180 patients consented, 36 excluded prior to study drug administration and 144 patients were randomized and enrolled.

Participants by arm

ArmCount
Olanzapine
10mg of olanzapine by mouth prior to anesthetic induction
71
Placebo
placebo by mouth prior to anesthetic induction
69
Total140

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studysurgery converted to open, pt admitted31

Baseline characteristics

CharacteristicPlaceboTotalOlanzapine
Age, Continuous37 years
STANDARD_DEVIATION 7
37 years
STANDARD_DEVIATION 7
37 years
STANDARD_DEVIATION 7
American Society of Anesthesiologists (ASA) Physical Status
I
24 Participants43 Participants19 Participants
American Society of Anesthesiologists (ASA) Physical Status
II
41 Participants90 Participants49 Participants
American Society of Anesthesiologists (ASA) Physical Status
III
4 Participants7 Participants3 Participants
Body Mass Index (BMI)27.7 kg/m^2
STANDARD_DEVIATION 5.9
27.7 kg/m^2
STANDARD_DEVIATION 6.1
27.8 kg/m^2
STANDARD_DEVIATION 6.3
Ethnicity (NIH/OMB)
Hispanic or Latino
27 Participants53 Participants26 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
42 Participants87 Participants45 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
History of postoperative nausea/vomiting17 Participants36 Participants19 Participants
Motion Sickness25 Participants46 Participants21 Participants
Nonsmoker62 Participants129 Participants67 Participants
Number of Risk Factors
2
7 Participants11 Participants4 Participants
Number of Risk Factors
3
35 Participants78 Participants43 Participants
Number of Risk Factors
4
27 Participants51 Participants24 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
14 Participants24 Participants10 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
27 Participants62 Participants35 Participants
Race (NIH/OMB)
White
28 Participants54 Participants26 Participants
Sex: Female, Male
Female
69 Participants140 Participants71 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Surgery type
Hysteroscopy
9 Participants20 Participants11 Participants
Surgery type
Laparoscopic gynecologic
58 Participants112 Participants54 Participants
Surgery type
Plastics
1 Participants4 Participants3 Participants
Surgery type
Vaginal
1 Participants4 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 710 / 69
other
Total, other adverse events
24 / 7127 / 69
serious
Total, serious adverse events
0 / 710 / 69

Outcome results

Primary

Number of Participants With Nausea and/or Vomiting

Number of participants with post-discharge nausea and/or vomiting

Time frame: in 24 hours after discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OlanzapineNumber of Participants With Nausea and/or Vomiting10 Participants
PlaceboNumber of Participants With Nausea and/or Vomiting26 Participants
p-value: 0.00395% CI: [0.48, 1.2]log-binomial regression
Primary

Number of Participants With Severe Nausea

Number 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)

Time frame: in 24 hours after discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OlanzapineNumber of Participants With Severe Nausea4 Participants
PlaceboNumber of Participants With Severe Nausea14 Participants
Secondary

Number of Participants With PONV

Number of participants with postoperative nausea and/or vomiting (PONV) in first 24 hours

Time frame: first 24 hours post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OlanzapineNumber of Participants With PONV22 Participants
PlaceboNumber of Participants With PONV35 Participants
Secondary

Number of Participants With Postdischarge Vomiting

Number of participants with post discharge vomiting

Time frame: in 24 hours after discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OlanzapineNumber of Participants With Postdischarge Vomiting2 Participants
PlaceboNumber of Participants With Postdischarge Vomiting8 Participants
Secondary

Number of Participants With Severe PONV

Number 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)

Time frame: first 24 hours post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OlanzapineNumber of Participants With Severe PONV12 Participants
PlaceboNumber of Participants With Severe PONV26 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026