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Completed

NCT Number: NCT05676294

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

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.
  • 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.
  • New York Heart Association Class II or higher congestive heart failure.
  • 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

Treatment and study plan

Olanzapine

Drug

5 mg of oral olanzapine one hour prior to ambulatory surgery

Other names: Zyprexa

Placebo

Drug

oral matched placebo one hour prior to ambulatory surgery

Primary outcomes

  1. Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy

    Time frame: 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 outcomes

  1. Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy

    Time frame: 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).

  2. Participants With Any Nausea

    Time frame: post-operative day 1

    Nausea was assessed using a numerical rating scale from 0 to 10, where 0 indicated no nausea and 10 indicated the worst nausea imaginable. For this outcome measure, participants were classified as having any nausea if they reported a nausea score greater than 0 at any assessment during the specified time period.

  3. Participants With Any Nausea

    Time frame: post-operative day 2

    Nausea was assessed using a numerical rating scale from 0 to 10, where 0 indicated no nausea and 10 indicated the worst nausea imaginable. For this outcome measure, participants were classified as having any nausea if they reported a nausea score greater than 0 at any assessment during the specified time period.

  4. Number of Participants With Severe Post-discharge Nausea

    Time frame: 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

  5. Recovery Room Length of Stay

    Time frame: From surgery end time to recovery room discharge, up to 23 hours

    Recovery room length of stay in minutes

  6. Recovery Room Opioid Consumption

    Time frame: From surgery end time to recovery room discharge, up to 23 hours

    Recovery room opioid consumption in morphine milligram equivalents

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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