The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this phase 2 randomized controlled trial is to determine whether the pre-operative administration of olanzapine (5 mg PO) improves quality of recovery (assessed by the Quality of Recovery-40 (QoR-40) survey) on postoperative day 1 in patients having ambulatory surgery with general anesthesia.

The secondary objectives of this study are to determine whether there are differences in quality of recovery on postoperative day 2, presence of post-discharge nausea, presence of severe post-discharge nausea, recovery room length of stay and opioid consumption in patients who receive the study drug versus placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Olanzapine

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