Postoperative Nausea and VomitingPhase 2NCT05676294
The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery
A Phase 2 study testing Olanzapine in people with Postoperative Nausea and Vomiting, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2023to 6 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: The Impact of Pre-operative Olanzapine on Quality of Recovery-40 Scores 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Olanzapine, Placebo
- Keywords
- olanzapine, placebo-controlled, nausea, vomiting, ambulatory surgery procedures, antiemetic, general anesthesia
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Zyprexa
5 mg of oral olanzapine one hour prior to ambulatory surgery
PlaceboDrug
oral matched placebo one hour prior to ambulatory surgery
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | olanzapine oral tablet, 5mg, once prior to surgery Receives: Drug: Olanzapine |
| Placebo | Placebo comparator | placebo oral tablet once prior to surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: post-operative day 1
Secondary outcomes (6)
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).
Measured: post-operative day 2
Participants With Any Nausea
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.
Measured: post-operative day 1
Participants With Any Nausea
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.
Measured: post-operative day 2
Number of Participants With 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
Measured: up to 24 hours post discharge
Recovery Room Length of Stay
Recovery room length of stay in minutes
Measured: From surgery end time to recovery room discharge, up to 23 hours
Recovery Room Opioid Consumption
Recovery room opioid consumption in morphine milligram equivalents
Measured: From surgery end time to recovery room discharge, up to 23 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start26 Jun 2023
- Primary completion5 Dec 2025
- Study completion6 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime B. Hyman, MD, Yale University
- Investigators
- Jaime Hyman, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676294
- Sponsor's protocol ID
- 2000033786
- Other IDs
- No NIH funding
- Status last verified
- May 2026
- First submitted
- 21 Dec 2022
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32229754Guzzi 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.
PubMed 42160634
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pre-operative Olanzapine on Quality of Recovery-40 Scores After Discharge From Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT05676294
- Acronym / sponsor ID
- 2000033786
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- olanzapine, placebo-controlled, nausea, vomiting, ambulatory surgery procedures, antiemetic, general anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 6 Dec 2025 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Posted 16 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: Olanzapineolanzapine oral tablet, 5mg, once prior to surgery |
| Placebo | Placebo comparator | Drug: Placeboplacebo oral tablet once prior to surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- Non-English speaking
- Unable to swallow pills
- Current use of anti-psychotic medications
- History of allergy to olanzapine
- Pregnancy/Lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlanzapineAlso: Zyprexa5 mg of oral olanzapine one hour prior to ambulatory surgery | Drug | Olanzapine |
| Placebooral matched placebo one hour prior to ambulatory surgery | Drug | Placebo |
Primary outcome
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).
6 secondary outcomes
Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy
Time frame: post-operative day 2
Participants With Any Nausea
Time frame: post-operative day 1
Participants With Any Nausea
Time frame: post-operative day 2
Number of Participants With Severe Post-discharge Nausea
Time frame: up to 24 hours post discharge
Recovery Room Length of Stay
Time frame: From surgery end time to recovery room discharge, up to 23 hours
Recovery Room Opioid Consumption
Time frame: From surgery end time to recovery room discharge, up to 23 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32229754Hyman 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.
- Derived from this study: PubMed 42160634Guzzi 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Hyman, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olanzapine in people with Postoperative Nausea and Vomiting, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy (time frame: post-operative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05676294, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.