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

Sponsor

Yale University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05676294

Collaborator

(none)

455

Enrollment

Location

Arms

Anticipated Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: Olanzapine Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

455 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olanzapine olanzapine oral tablet, 5mg, once prior to surgery	Drug: Olanzapine 5 mg of oral olanzapine one hour prior to ambulatory surgery Other Names: Zyprexa
Placebo Comparator: Placebo placebo oral tablet once prior to surgery	Drug: Placebo oral matched placebo one hour prior to ambulatory surgery

Arm

Intervention/Treatment

Experimental: Olanzapine

olanzapine oral tablet, 5mg, once prior to surgery

Drug: Olanzapine

5 mg of oral olanzapine one hour prior to ambulatory surgery

Other Names:

Zyprexa

Placebo Comparator: Placebo

placebo oral tablet once prior to surgery

Drug: Placebo

oral matched placebo one hour prior to ambulatory surgery

Outcome Measures

Primary Outcome Measures

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

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).
Nausea [post-operative day 1]
Presence of nausea on post-operative day 1 will be rated on a 0 to 10 numerical rating scale with 0 being "none" and 10 being "worst nausea imaginable"
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"
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
Recovery room opioid consumption [From surgery end time to recovery room discharge, up to 23 hours]
Recovery room opioid consumption in morphine milligram equivalents

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.