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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours post discharge

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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

31%

Increased appetite

31%

Hypersalivation

17%

tachycardia >100 beats/min (supine)

15%

Constipation

15%

Somnolence

Hypertension

Abnormal white blood count

Difficulty concentrating

Insomnia

Enuresis

100%

80%

60%

40%

20%

Study treatment Arm

Olanzapine Group

Clozapine 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

~5480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,106 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age qualification of this study greater than a quarter-century?

"The requirements for this clinical trial outlines that the age range of participants should fall between 18 and 50. For those outside of these parameters, there are 20 studies targeting minors and 82 trials catered to senior citizens."

Answered by AI

Has the FDA given clearance to Olanzapine?

"Based on the existing evidence, our evaluation gives Olanzapine a safety rating of 2. This medication is currently in its second phase of clinical trials and while there are some studies showing safety data, none have determined efficacy yet."

Answered by AI

Are there eligibility criteria to become involved in this research endeavor?

"This study seeks to enrol 455 individuals aged 18-50 who suffer from postoperative nausea and vomiting. Potential participants must meet the following criteria: provide a signed, dated informed consent form; be able and willing to follow all protocol procedures throughout the trial's duration; have access to an internet connected device or computer with email capabilities."

Answered by AI

Are new participants still being accepted into this experiment?

"As per clinicaltrials.gov, this trial is not currently accepting new participants; the original post was published on January 1st 2023 and updated for a final time on June 1st of that same year. Despite this, there are still 109 trials open to enrollees at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jaime B. Hyman, MD 2023. "The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05676294.