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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 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
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 moreSide effects data
From 2008 Phase 4 trial • 25 Patients • NCT0000165670%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication for high blood pressure.I cannot swallow pills.I have an active tumor that affects my prolactin levels.I have a liver condition.I am willing and able to follow all study rules and be available for its duration.I am currently taking medication for psychosis.I am scheduled for a surgery that requires me to be asleep.I have diabetes.I have been diagnosed with Lewy body dementia.I have Parkinson's disease.I have fainted or felt dizzy upon standing up in the last 6 months.I haven't had a heart attack or unstable chest pain in the last 6 months.I have a seizure disorder.I am a woman aged between 18 and 50.I have a history of serious heart rhythm problems but not well-controlled atrial fibrillation.I have moderate to severe heart failure.I have narrow angle glaucoma.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Olanzapine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.