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

Phase 2

Recruiting

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Olanzapine; Drug: Placebo

• Registration Number: NCT05676294
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-09
• Study Start: 2023-06-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 455

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine	Olanzapine	olanzapine oral tablet, 5mg, once prior to surgery
Placebo	Placebo	placebo oral tablet once prior to surgery

Primary Outcome Measures

Name	Time	Method
Quality of Recovery-40 (QoR-40) survey to assess efficacy	post-operative day 1	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).

Secondary Outcome Measures

Name	Time	Method
Nausea	post-operative day 2	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"
Recovery room opioid consumption	From surgery end time to recovery room discharge, up to 23 hours	Recovery room opioid consumption in morphine milligram equivalents
Quality of Recovery-40 (QoR-40) survey to assess efficacy	post-operative day 2	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).
Severe post-discharge nausea	up to 24 hours post discharge	Severe post-discharge nausea defined as any numerical rating \> 3 on a 0-10 scale during the 24 hours after discharge
Recovery room length of stay	From surgery end time to recovery room discharge, up to 23 hours	Recovery room length of stay in minutes

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States