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

NCT05676294 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2025-12-15

No results posted yet for this study

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

Interventions

DRUG

Olanzapine

5 mg of oral olanzapine one hour prior to ambulatory surgery

DRUG

Placebo

oral matched placebo one hour prior to ambulatory surgery

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Jaime Hyman, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2025-12-05
Completion
2025-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05676294 on ClinicalTrials.gov