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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

The Impact of Pre-operative Olanzapine on Quality of Recovery-40 Scores After Discharge From Ambulatory Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676294
• Other study ID #: 2000033786
• Secondary ID: No NIH funding
• Status: Recruiting
• Phase: Phase 2
• Start date: June 26, 2023
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: Jaime Hyman, MD
• Phone: 203-499-9136
• Email: Jaime.Hyman[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Up to 37% of patients undergoing ambulatory surgery experience postdischarge nausea and vomiting (PDNV), and PDNV represents a major barrier to improving a patient's quality of recovery. Because olanzapine has been shown to be an effective drug for PDNV prevention, but carries the risk of sedation, this study seeks to identify if the administration of olanzapine is an intervention that improves a patient's overall quality of recovery.

The study population includes women between 18 and 50 years-old who are undergoing ambulatory (outpatient) surgery at Yale New Haven Hospital. This represents the population that is most susceptible to post-discharge nausea and vomiting (PDNV) and is therefore most likely to benefit from an intervention that reduces PDNV to impact overall quality of recovery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 455
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.

2. 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.

3. New York Heart Association Class II or higher congestive heart failure.

4. 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

• Hepatic disease

• Narrow angle glaucoma

• Parkinson's disease

• Lewy body dementia

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Olanzapine
5 mg of oral olanzapine one hour prior to ambulatory surgery
• Placebo
oral matched placebo one hour prior to ambulatory surgery

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & 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. Erratum In: Anesthesiology. 2020 Jun 5;: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 2
Secondary	Nausea	Presence of nausea on post-operative day 1 will be rated on a 0 to 10 numerical rating scale with 0 being "none" and 10 being "worst nausea imaginable"	post-operative day 1
Secondary	Nausea	Presence of nausea on post-operative day 2 will be rated on a 0 to 10 numerical rating scale with 0 being "none" and 10 being "worst nausea imaginable"	post-operative day 2
Secondary	Severe post-discharge nausea	Severe post-discharge nausea defined as any numerical rating > 3 on a 0-10 scale during the 24 hours after discharge	up to 24 hours post discharge
Secondary	Recovery room length of stay	Recovery room length of stay in minutes	From surgery end time to recovery room discharge, up to 23 hours
Secondary	Recovery room opioid consumption	Recovery room opioid consumption in morphine milligram equivalents	From surgery end time to recovery room discharge, up to 23 hours