Using olanzapine to improve recovery after outpatient surgery
The Impact of Pre-operative Olanzapine on Quality of Recovery-40 Scores After Discharge from Ambulatory Surgery
This study is testing if taking olanzapine before outpatient surgery can help women aged 18 to 50 recover better and feel less nausea after anesthesia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 455 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05676294 on ClinicalTrials.gov |
What this trial studies
This phase 2 randomized controlled trial investigates the effects of preoperative olanzapine on the quality of recovery in patients undergoing ambulatory surgery with general anesthesia. The primary goal is to assess whether olanzapine improves recovery quality, measured by the Quality of Recovery-40 survey, on the first postoperative day. Secondary objectives include evaluating recovery quality on the second postoperative day, incidence of post-discharge nausea, recovery room length of stay, and opioid consumption compared to a placebo group. The study focuses on women aged 18 to 50, who are particularly vulnerable to postoperative nausea and vomiting.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 50 scheduled for ambulatory surgery under general anesthesia.
Not a fit: Patients who are non-English speaking, pregnant, or have significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the recovery experience for patients undergoing outpatient surgery by reducing postoperative nausea and vomiting.
How similar studies have performed: Previous studies have indicated that olanzapine is effective in preventing postoperative nausea and vomiting, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Female aged 18-50 * Scheduled to undergo ambulatory surgery under general anesthesia * Access to smartphone device or computer with internet connection and has an email address Exclusion Criteria: * Non-English speaking * Unable to swallow pills * Current use of anti-psychotic medications * History of allergy to olanzapine * Pregnancy/Lactation * 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 Class II or higher congestive heart failure. 4. Postural hypotension or vasovagal syncope within 6 months of planned surgery. * Hypotension on day of surgery, defined as a systolic blood pressure \< 90mmHg * Seizure disorder * Clinically active prolactinoma * Hepatic disease * Narrow angle glaucoma * Parkinson's disease * Lewy body dementia
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Jaime Hyman, MD — Yale University
- Study coordinator: Jaime Hyman, MD
- Email: Jaime.Hyman@yale.edu
- Phone: 203-499-9136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.