Postoperative Nausea and VomitingPhase 2NCT02755116
Olanzapine for Nausea After Surgery
A Phase 2 study testing Olanzapine in people with Postoperative Nausea and Vomiting, run by Jaime B Hyman at 1 site in United States.
Trial summary
Ambulatory surgery is occurring with rapidly increasing frequency as surgical and anesthetic techniques have improved and pressure to reduce health-care costs has increased. While there are many benefits to recovering from surgery within the home, a significant disadvantage is the lack of rapid access to a healthcare… 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
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 5 Sep 2019
- 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
- Adults age ≥ 18 and ≤ 50 years old
- Patient scheduled to undergo ambulatory surgery under general anesthesia
- Willing and able to provide informed consent
Who cannot join
- Unable to swallow pills
- Current use of typical or atypical anti-psychotic medications
- History of allergy to olanzapine
- Pregnancy/Lactation (subjects of child-bearing potential will have a urine pregnancy test performed the day of surgery)
- History of QTc > 450ms or torsades de pointes
- Current use of antihypertensive medication
Show all 21Show 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 (NYHA) 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 < 90mm Hg or a diastolic pressure < 60mm Hg.
- Seizure disorder
- Clinically active prolactinoma
- Hepatic disease
- Poorly controlled diabetes
- Pre-operative blood glucose > 250 mg/dL
- Narrow angle glaucoma
- Parkinson's disease
- Lewy body dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Olanzapine for the Treatment of Post-Discharge Nausea and Vomiting After Ambulatory Surgery
Ambulatory surgery is occurring with rapidly increasing frequency as surgical and anesthetic techniques have improved and pressure to reduce health-care costs has increased. While there are many benefits to recovering from surgery within the home, a significant disadvantage is the lack of rapid access to a healthcare provider when postoperative complications occur. Postoperative nausea and vomiting (PONV) are common after surgery and anesthesia, and recent studies have demonstrated a high incidence of post-discharge nausea and vomiting (PDNV) after ambulatory surgery, particularly in high-risk groups (female gender, age less than 50 years, history of PONV, opioid administration in the post-anesthesia care unit (PACU), and nausea in the PACU). Current practices known to reduce the risk of postoperative nausea and vomiting in the PACU, such as the avoidance of volatile anesthetics and the use of intraoperative ondansetron and steroids, have little effect on the risk of delayed PDNV. Novel strategies to prevent PDNV are needed. Orally administered olanzapine, which has been shown to decrease the incidence of chemotherapy-induced nausea and vomiting, demonstrates promise as a novel strategy for preventing PDNV. It has a long half-life, allowing for a single dose to be administered preoperatively. This study will evaluate whether there is a difference in the incidence and severity of PDNV between patients who receive oral olanzapine versus placebo prior to general anesthesia for ambulatory surgery.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Olanzapine, Placebo
- Keywords
- Nausea, Vomiting
- 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, 132539-06-1, Zyprexa Zydis, Olansek
10mg of olanzapine by mouth prior to anesthetic induction
PlaceboDrug
placebo by mouth prior to anesthetic induction
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | 10mg pill Receives: Drug: Olanzapine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Nausea and/or Vomiting
Number of participants with post-discharge nausea and/or vomiting
Measured: in 24 hours after discharge
Number of Participants With Severe Nausea
Number of participants with severe postdischarge nausea, defined as numerical rating scale score greater than 3. (11-point numerical rating scale from 0-10, higher score indicating worse nausea)
Measured: in 24 hours after discharge
Secondary outcomes (3)
Number of Participants With Postdischarge Vomiting
Number of participants with post discharge vomiting
Measured: in 24 hours after discharge
Number of Participants With PONV
Number of participants with postoperative nausea and/or vomiting (PONV) in first 24 hours
Measured: first 24 hours post-op
Number of Participants With Severe PONV
Number of participants with severe PONV in first 24 hours after post-op.defined as numerical rating scale score greater than 3. (11-point numerical rating scale from 0-10, higher score indicating worse nausea)
Measured: first 24 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaime B Hyman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaime B Hyman, Icahn School of Medicine at Mount Sinai
- Investigators
- Jaime B Hyman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755116
- Sponsor's protocol ID
- GCO 15-1297
- Status last verified
- Jul 2020
- First submitted
- 25 Apr 2016
- Last updated
- 27 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Apfel CC, Philip BK, Cakmakkaya OS, Shilling A, Shi YY, Leslie JB, Allard M, Turan A, Windle P, Odom-Forren J, Hooper VD, Radke OC, Ruiz J, Kovac A. Who is at risk for postdischarge nausea and vomiting after ambulatory surgery? Anesthesiology. 2012 Sep;117(3):475-86. doi: 10.1097/ALN.0b013e318267ef31.
PubMed 22846680Hyman 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 32229754
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine for the Treatment of Post-Discharge Nausea and Vomiting After Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT02755116
- Acronym / sponsor ID
- GCO 15-1297
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Nausea, Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Jaime B HymanUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 27 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ambulatory surgery is occurring with rapidly increasing frequency as surgical and anesthetic techniques have improved and pressure to reduce health-care costs has increased. While there are many benefits to recovering from surgery within the home, a significant disadvantage is the lack of rapid access to a healthcare provider when postoperative complications occur. Postoperative nausea and vomiting (PONV) are common after surgery and anesthesia, and recent studies have demonstrated a high incidence of post-discharge nausea and vomiting (PDNV) after ambulatory surgery, particularly in high-risk groups (female gender, age less than 50 years, history of PONV, opioid administration in the post-anesthesia care unit (PACU), and nausea in the PACU). Current practices known to reduce the risk of postoperative nausea and vomiting in the PACU, such as the avoidance of volatile anesthetics and the use of intraoperative ondansetron and steroids, have little effect on the risk of delayed PDNV. Novel strategies to prevent PDNV are needed. Orally administered olanzapine, which has been shown to decrease the incidence of chemotherapy-induced nausea and vomiting, demonstrates promise as a novel strategy for preventing PDNV. It has a long half-life, allowing for a single dose to be administered preoperatively. This study will evaluate whether there is a difference in the incidence and severity of PDNV between patients who receive oral olanzapine versus placebo prior to general anesthesia for ambulatory surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: Olanzapine10mg pill |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults age ≥ 18 and ≤ 50 years old
- Patient scheduled to undergo ambulatory surgery under general anesthesia
- Willing and able to provide informed consent
Key exclusion criteria (21 listed)
- Unable to swallow pills
- Current use of typical or atypical anti-psychotic medications
- History of allergy to olanzapine
- Pregnancy/Lactation (subjects of child-bearing potential will have a urine pregnancy test performed the day of surgery)
- History of QTc > 450ms or torsades de pointes
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: Zyprexa, 132539-06-1, Zyprexa Zydis, Olansek10mg of olanzapine by mouth prior to anesthetic induction | Drug | Olanzapine |
| Placeboplacebo by mouth prior to anesthetic induction | Drug | Placebo |
Primary outcome
Number of Participants With Nausea and/or Vomiting
Time frame: in 24 hours after discharge
Number of participants with post-discharge nausea and/or vomiting
Number of Participants With Severe Nausea
Time frame: in 24 hours after discharge
Number of participants with severe postdischarge nausea, defined as numerical rating scale score greater than 3. (11-point numerical rating scale from 0-10, higher score indicating worse nausea)
3 secondary outcomes
Number of Participants With Postdischarge Vomiting
Time frame: in 24 hours after discharge
Number of Participants With PONV
Time frame: first 24 hours post-op
Number of Participants With Severe PONV
Time frame: first 24 hours post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22846680Apfel CC, Philip BK, Cakmakkaya OS, Shilling A, Shi YY, Leslie JB, Allard M, Turan A, Windle P, Odom-Forren J, Hooper VD, Radke OC, Ruiz J, Kovac A. Who is at risk for postdischarge nausea and vomiting after ambulatory surgery? Anesthesiology. 2012 Sep;117(3):475-86. doi: 10.1097/ALN.0b013e318267ef31.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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 B Hyman, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Jaime B Hyman 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 3 inclusion and 21 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 27 Jul 2020. 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 27 Jul 2020). 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?
Number of Participants With Nausea and/or Vomiting (time frame: in 24 hours after discharge). The study lists 2 primary outcomes in all. 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 NCT02755116, 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 27 Jul 2020.