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

NCT05676294 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 2000033786No NIH funding
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

olanzapine; placebo-controlled; nausea; vomiting; ambulatory surgery procedures; antiemetic; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Quality of Recovery-40 (QoR-40) survey to assess efficacy

  post-operative day 2

• Nausea

  post-operative day 1

• Nausea

  post-operative day 2

• Severe post-discharge nausea

  up to 24 hours post discharge

• Recovery room length of stay

  From surgery end time to recovery room discharge, up to 23 hours

Study Arms (2)

Olanzapine

EXPERIMENTAL

olanzapine oral tablet, 5mg, once prior to surgery

Drug: Olanzapine

Placebo

PLACEBO COMPARATOR

placebo oral tablet once prior to surgery

Drug: Placebo

Interventions

Olanzapine DRUG

5 mg of oral olanzapine one hour prior to ambulatory surgery

Also known as: Zyprexa

Olanzapine

Placebo DRUG

oral matched placebo one hour prior to ambulatory surgery

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.
• 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.
• New York Heart Association Class II or higher congestive heart failure.
• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

• 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.

  PMID: 32229754 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jaime Hyman, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 9, 2023
• Study Start: June 26, 2023
• Primary Completion: December 5, 2025
• Study Completion: December 6, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)