Olanzapine for Nausea After Surgery

NCT ID: NCT02755116

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-09-05

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Olanzapine

10mg pill

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

10mg of olanzapine by mouth prior to anesthetic induction

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo by mouth prior to anesthetic induction

Interventions

Olanzapine

10mg of olanzapine by mouth prior to anesthetic induction

Intervention Type: DRUG

Placebo

placebo by mouth prior to anesthetic induction

Intervention Type: DRUG

Other Intervention Names

Zyprexa; 132539-06-1; Zyprexa Zydis; Olansek; Symbyax2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine

Eligibility Criteria

Inclusion Criteria

• Adults age ≥ 18 and ≤ 50 years old
• Patient scheduled to undergo ambulatory surgery under general anesthesia
• Willing and able to provide informed consent

Exclusion Criteria

• 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
• Diabetes Mellitus
• Clinically significant cardiovascular disease defined as follows:

1. Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.

2. 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.

3. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jaime B Hyman

OTHER

Sponsor Role: lead

Responsible Party

Jaime B Hyman

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jaime B Hyman, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22846680 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32229754 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 15-1297

Identifier Type: -

Identifier Source: org_study_id