Olanzapine for the Prevention of Postoperative Nausea and Vomiting

Olanzapine for the Prevention of Postoperative Nausea and Vomiting After Laparoscopic Surgery in High-risk Patients: A Randomized Controlled Trial

Nausea and vomiting (PONV) remain a common problem in surgical units. Even after two or three prophylactic antiemetic interventions, patients with all four of the Apfel risk factors for PONV have an estimated 30 to 40% chance of suffering PONV. Olanzapine as an antiemetic represents a new use of an antipsychotic drug.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea
• Intervention / Treatment: Drug: Placebo; Drug: 5 mg Olanzapine Tablets; Drug: 10 mg Olanzapine Tablets

Detailed Description

Aim of the Research, to compare the effects of oral 10 and 5 mg Olanzapine for the Prevention of Postoperative Nausea and Vomiting

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Amani H Abdel-wahab, MD; Phone Number: 01004610623; Email: amanyabdelwhab@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University
  • Assiut Governorate
    • Assiut, Assiut Governorate, Egypt, Egypt, 715715
      • Assiut university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA I and II patients
• undergoing ambulatory laparoscopic gynecologic surgery with general anesthesia
• patients have at least two of the four Apfel risk factors for PONV2
• Lack of history of psychiatric and psychotic illnesses.

Exclusion Criteria:

• ASA III and ≥ IV patients
• Psychological diseases
• History of chemotherapy
• have a pre-existing vestibular disorder or history of dizziness or preexisting nausea or vomiting in the 24 h before surgery, or were being treated with regular antiemetic therapy including systemic corticosteroids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1; patients will receive oral placebo tablets one hour preoperatively	Drug: Placebo; oral Placebo tablets one-hour preoperatively
Active Comparator: Group 2; patients will receive oral 5 mg Olanzapine tablets one hour preoperatively	Drug: 5 mg Olanzapine Tablets; oral 5 mg Olanzapine tablets one-hour preoperatively; Other Names: zyprexa
Active Comparator: Group 3; patients will receive oral 10 mg Olanzapine tablets one hour preoperatively	Drug: 10 mg Olanzapine Tablets; oral 10 mg Olanzapine tablets one-hour preoperatively; Other Names: zyprexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nausea and/or vomiting score	the occurrence of nausea and/or vomiting by nausea score	first 24 hours postoperative

Collaborators and Investigators

• Sponsor: Amani Hassan Abdel-Wahab
• Investigators: Principal Investigator: Amani H Abdel-wahab, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: January 17, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: IRB: 17300536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No