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

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: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Olanzapine; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 384
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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
Nausea	Presence of nausea on post-operative day 1 will be rated on a 0 to 10 numerical rating scale with 0 being "none" and 10 being "worst nausea imaginable"	post-operative day 1
Nausea	Presence of nausea on post-operative day 2 will be rated on a 0 to 10 numerical rating scale with 0 being "none" and 10 being "worst nausea imaginable"	post-operative day 2
Severe post-discharge nausea	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	Recovery room length of stay in minutes	From surgery end time to recovery room discharge, up to 23 hours
Recovery room opioid consumption	Recovery room opioid consumption in morphine milligram equivalents	From surgery end time to recovery room discharge, up to 23 hours

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Jaime Hyman, MD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

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 (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: general anesthesia; nausea; olanzapine; vomiting; placebo-controlled; antiemetic; ambulatory surgery procedures
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nausea; Vomiting; Postoperative Nausea and Vomiting; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Benzodiazepines; Olanzapine
• Other Study ID Numbers: 2000033786; No NIH funding (Other Identifier: 11.16.23)

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