Clinical trial NCT05676294: The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge from Ambulatory Surgery
Official title: The Impact of Pre-operative Olanzapine on Quality of Recovery-40 Scores After Discharge from Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Keywords: olanzapine
placebo-controlled
nausea
vomiting
ambulatory surgery procedures
antiemetic
general anesthesia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 455
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery-40 (QoR-40) survey to assess efficacy
timeFrame: post-operative day 1
Secondary outcomes:
measure: Quality of Recovery-40 (QoR-40) survey to assess efficacy
timeFrame: post-operative day 2
measure: Nausea
timeFrame: post-operative day 1
measure: Nausea
timeFrame: post-operative day 2
measure: Severe post-discharge nausea
timeFrame: up to 24 hours post discharge
measure: Recovery room length of stay
timeFrame: From surgery end time to recovery room discharge, up to 23 hours
measure: Recovery room opioid consumption
timeFrame: From surgery end time to recovery room discharge, up to 23 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Jaime Hyman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.