Olanzapine for Nausea After Surgery

NCT02755116 | Completed Phase 2 Results

• 1 other identifier: GCO 15-1297
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

Nausea; Vomiting

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Nausea and/or Vomiting

  Number of participants with post-discharge nausea and/or vomiting

  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)

  in 24 hours after discharge

Secondary Outcomes (3)

• Number of Participants With Postdischarge Vomiting

  in 24 hours after discharge

• Number of Participants With PONV

  first 24 hours post-op

• Number of Participants With Severe PONV

  first 24 hours post-op

Study Arms (2)

Olanzapine

EXPERIMENTAL

10mg pill

Drug: Olanzapine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Olanzapine DRUG

10mg of olanzapine by mouth prior to anesthetic induction

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

Olanzapine

Placebo DRUG

placebo by mouth prior to anesthetic induction

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Jaime B Hyman: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

• 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.

  PMID: 22846680 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.

  PMID: 32229754 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jaime B. Hyman
• Organization: Icahn School of Medicine at Mount Sinai

Jaime.hyman@mountsinai.org

212-241-7473

Study Officials

• Jaime B Hyman, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 28, 2016
• Study Start: April 1, 2016
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: July 27, 2020
• Results First Posted: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)