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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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05676294
Study type Interventional
Source Yale University
Contact Jaime Hyman, MD
Phone 203-499-9136
Email Jaime.Hyman@yale.edu
Status Recruiting
Phase Phase 2
Start date June 26, 2023
Completion date January 2026
View Details
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