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Antipsychotic

Olanzapine for Post-Surgery Recovery

Phase 2
Recruiting
Led By Jaime Hyman, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours post discharge

Summary

This trial tests if a drug can help after surgery to improve quality of recovery and reduce post-op nausea and opioid use.

Who is the study for?
This trial is for women aged 18-50 who are scheduled for ambulatory surgery with general anesthesia and can access the internet. They must not have severe heart, liver, or blood pressure conditions, seizure disorders, certain eye diseases, Parkinson's disease or related dementia. Participants should not be on antipsychotics or antihypertensives, diabetic, allergic to olanzapine, pregnant or breastfeeding.
What is being tested?
The study tests if taking Olanzapine (5 mg) before surgery improves recovery quality compared to a placebo. Recovery is measured by a survey on postoperative days 1 and 2. The trial also looks at nausea after discharge, opioid use and how long patients stay in the recovery room.
What are the potential side effects?
Olanzapine may cause side effects like drowsiness, restlessness, weight gain and dry mouth. It might also lead to more serious issues such as changes in blood pressure or abnormal heart rhythms but these are less common.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours post discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours post discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Nausea
Quality of Recovery-40 (QoR-40) survey to assess efficacy
Recovery room length of stay
+2 more

Side effects data

From 2008 Phase 4 trial • 25 Patients • NCT00001656
70%
tachycardia >100 beats/min (supine)
67%
Hypersalivation
64%
Hypertension
42%
Enuresis
33%
Increased appetite
33%
Difficulty concentrating
25%
Insomnia
17%
Abnormal white blood count
17%
Somnolence
17%
Constipation
10%
Tachycardia >120 beats/min (supine)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clozapine Group
Olanzapine Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OlanzapineExperimental Treatment1 Intervention
olanzapine oral tablet, 5mg, once prior to surgery
Group II: PlaceboPlacebo Group1 Intervention
placebo oral tablet once prior to surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olanzapine
2005
Completed Phase 4
~5030

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,019 Total Patients Enrolled
1 Trials studying Postoperative Nausea and Vomiting
800 Patients Enrolled for Postoperative Nausea and Vomiting
Jaime Hyman, MDPrincipal InvestigatorYale University
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Olanzapine (Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05676294 — Phase 2
Postoperative Nausea and Vomiting Research Study Groups: Placebo, Olanzapine
Postoperative Nausea and Vomiting Clinical Trial 2023: Olanzapine Highlights & Side Effects. Trial Name: NCT05676294 — Phase 2
Olanzapine (Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05676294 — Phase 2
~182 spots leftby Jan 2026