NCT05676294

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Olanzapine	5 mg of oral olanzapine one hour prior to ambulatory surgery
DRUG	Placebo	oral matched placebo one hour prior to ambulatory surgery

Timeline

• Start date: 2023-06-26
• Primary completion: 2025-12-05
• Completion: 2025-12-06
• First posted: 2023-01-09
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study