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| ID | Type | Description | Link |
|---|---|---|---|
| No NIH funding | Other Identifier | 12.06.23 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine | Experimental | olanzapine oral tablet, 5mg, once prior to surgery |
|
| Placebo | Placebo Comparator | placebo oral tablet once prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | 5 mg of oral olanzapine one hour prior to ambulatory surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | post-operative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Hyman, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32229754 | Background | 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. | |
| 42160634 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2026 | Jun 18, 2026 | 8 | ||
| Jun 18, 2026 |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | oral matched placebo one hour prior to ambulatory surgery |
|
| post-operative day 2 |
| 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" | post-operative day 1 |
| 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" | post-operative day 2 |
| 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 | up to 24 hours post discharge |
| Recovery room length of stay | Recovery room length of stay in minutes | From surgery end time to recovery room discharge, up to 23 hours |
| Recovery room opioid consumption | Recovery room opioid consumption in morphine milligram equivalents | From surgery end time to recovery room discharge, up to 23 hours |
| Guzzi J, Gugel T, Fernandez Robles C, Herrera A, Zhao X, Shapiro A, Fernandez T, Longley M, Stephan A, Nguyen HP, Valedon A, Tanaka C, Belkasim S, Gilmore ML, Lin HM, Hyman JB. Preoperative Olanzapine and Quality of Recovery after Ambulatory Surgery: A Randomized Clinical Trial. Anesthesiology. 2026 May 20. doi: 10.1097/ALN.0000000000006166. Online ahead of print. |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |