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

NCT ID: NCT05676294

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2025-12-06

Brief 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.

Detailed Description

Up to 37% of patients undergoing ambulatory surgery experience postdischarge nausea and vomiting (PDNV), and PDNV represents a major barrier to improving a patient's quality of recovery. Because olanzapine has been shown to be an effective drug for PDNV prevention, but carries the risk of sedation, this study seeks to identify if the administration of olanzapine is an intervention that improves a patient's overall quality of recovery.

The study population includes women between 18 and 50 years-old who are undergoing ambulatory (outpatient) surgery at Yale New Haven Hospital. This represents the population that is most susceptible to post-discharge nausea and vomiting (PDNV) and is therefore most likely to benefit from an intervention that reduces PDNV to impact overall quality of recovery.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Olanzapine

olanzapine oral tablet, 5mg, once prior to surgery

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

5 mg of oral olanzapine one hour prior to ambulatory surgery

Placebo

placebo oral tablet once prior to surgery

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral matched placebo one hour prior to ambulatory surgery

Interventions

Olanzapine

5 mg of oral olanzapine one hour prior to ambulatory surgery

Intervention Type: DRUG

Placebo

oral matched placebo one hour prior to ambulatory surgery

Intervention Type: DRUG

Other Intervention Names

Zyprexa

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Jaime B. Hyman, MD

Associate Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaime Hyman, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

References

Hyman JB, Park C, Lin HM, Cole B, Rosen L, Fenske SS, Barr Grzesh RL, Blank SV, Polsky SB, Hartnett M, Taub PJ, Palvia V, DeMaria S Jr, Ascher-Walsh C. Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery: A Randomized Controlled Trial. Anesthesiology. 2020 Jun;132(6):1419-1428. doi: 10.1097/ALN.0000000000003286.

Reference Type: BACKGROUND

PMID: 32229754 (View on PubMed)

Other Identifiers

No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000033786

Identifier Type: -

Identifier Source: org_study_id