Back to resultsThe Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery
Primary Purpose
Postoperative Nausea and Vomiting
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Olanzapine
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Nausea and Vomiting focused on measuring olanzapine, placebo-controlled, nausea, vomiting, ambulatory surgery procedures, antiemetic, general anesthesia
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: 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
Sites / Locations
- Yale New Haven HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Olanzapine
Placebo
Arm Description
olanzapine oral tablet, 5mg, once prior to surgery
placebo oral tablet once prior to surgery
Outcomes
Primary Outcome Measures
Quality of Recovery-40 (QoR-40) survey to assess efficacy
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
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
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
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
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
Recovery room length of stay in minutes
Recovery room opioid consumption
Recovery room opioid consumption in morphine milligram equivalents
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05676294
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
olanzapine, placebo-controlled, nausea, vomiting, ambulatory surgery procedures, antiemetic, general anesthesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
455 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
olanzapine oral tablet, 5mg, once prior to surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo oral tablet once prior to surgery
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
5 mg of oral olanzapine one hour prior to ambulatory surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral matched placebo one hour prior to ambulatory surgery
Primary Outcome Measure Information:
Title
Quality of Recovery-40 (QoR-40) survey to assess efficacy
Description
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).
Time Frame
post-operative day 1
Secondary Outcome Measure Information:
Title
Quality of Recovery-40 (QoR-40) survey to assess efficacy
Description
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).
Time Frame
post-operative day 2
Title
Nausea
Description
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"
Time Frame
post-operative day 1
Title
Nausea
Description
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"
Time Frame
post-operative day 2
Title
Severe post-discharge nausea
Description
Severe post-discharge nausea defined as any numerical rating > 3 on a 0-10 scale during the 24 hours after discharge
Time Frame
up to 24 hours post discharge
Title
Recovery room length of stay
Description
Recovery room length of stay in minutes
Time Frame
From surgery end time to recovery room discharge, up to 23 hours
Title
Recovery room opioid consumption
Description
Recovery room opioid consumption in morphine milligram equivalents
Time Frame
From surgery end time to recovery room discharge, up to 23 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Hyman, MD
Phone
203-499-9136
Email
Jaime.Hyman@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John Guzzi, MD
Phone
203-824-8752
Email
john.guzzi@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Hyman, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
32229754
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. Erratum In: Anesthesiology. 2020 Jun 5;:
Results Reference
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The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery
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