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

June 18, 2026 updated by: Jaime B. Hyman, MD, Yale University

The Impact of Pre-operative Olanzapine on Quality of Recovery-40 Scores After Discharge From Ambulatory Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

398

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olanzapine
olanzapine oral tablet, 5mg, once prior to surgery
Drug: Olanzapine
5 mg of oral olanzapine one hour prior to ambulatory surgery
Other Names:
  • Zyprexa
Placebo Comparator: Placebo
placebo oral tablet once prior to surgery
Drug: Placebo
oral matched placebo one hour prior to ambulatory surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy
Time Frame: post-operative day 1
Quality of Recovery-40 (QoR-40) survey is a 40-item questionnaire that provides a global score across five dimensions: patient support, comfort, emotions, physical independence, and pain. The survey is scored on a 5-point Likert scale: for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
post-operative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy
Time Frame: post-operative day 2
Quality of Recovery-40 (QoR-40) survey is a 40-item questionnaire that provides a global score across five dimensions: patient support, comfort, emotions, physical independence, and pain. The survey is scored on a 5-point Likert scale: for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
post-operative day 2
Participants With Any Nausea
Time Frame: post-operative day 1
Nausea was assessed using a numerical rating scale from 0 to 10, where 0 indicated no nausea and 10 indicated the worst nausea imaginable. For this outcome measure, participants were classified as having any nausea if they reported a nausea score greater than 0 at any assessment during the specified time period.
post-operative day 1
Participants With Any Nausea
Time Frame: post-operative day 2
Nausea was assessed using a numerical rating scale from 0 to 10, where 0 indicated no nausea and 10 indicated the worst nausea imaginable. For this outcome measure, participants were classified as having any nausea if they reported a nausea score greater than 0 at any assessment during the specified time period.
post-operative day 2
Number of Participants With Severe Post-discharge Nausea
Time Frame: up to 24 hours post discharge
Severe post-discharge nausea defined as any numerical rating > 3 on a 0-10 scale during the 24 hours after discharge
up to 24 hours post discharge
Recovery Room Length of Stay
Time Frame: From surgery end time to recovery room discharge, up to 23 hours
Recovery room length of stay in minutes
From surgery end time to recovery room discharge, up to 23 hours
Recovery Room Opioid Consumption
Time Frame: From surgery end time to recovery room discharge, up to 23 hours
Recovery room opioid consumption in morphine milligram equivalents
From surgery end time to recovery room discharge, up to 23 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Jaime Hyman, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2023

Primary Completion (Actual)

December 5, 2025

Study Completion (Actual)

December 6, 2025

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000033786
  • No NIH funding (Other Identifier: 10.20.23)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe