Olanzapine for the Prevention of Postoperative Nausea and Vomiting

Phase 1

Completed

• Conditions: Postoperative Nausea
• Interventions: Drug: Placebo; Drug: 5 mg Olanzapine Tablets; Drug: 10 mg Olanzapine Tablets

• Registration Number: NCT04718727
• Lead Sponsor: Amani Hassan Abdel-Wahab

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Study Start: 2021-03-15
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Placebo	patients will receive oral placebo tablets one hour preoperatively
Group 2	5 mg Olanzapine Tablets	patients will receive oral 5 mg Olanzapine tablets one hour preoperatively
Group 3	10 mg Olanzapine Tablets	patients will receive oral 10 mg Olanzapine tablets one hour preoperatively

Primary Outcome Measures

Name	Time	Method
nausea and/or vomiting score	first 24 hours postoperative	the occurrence of nausea and/or vomiting by nausea score

Trial Locations

Locations (2)

Assiut university; 🇪🇬 Assiut, Egypt

Assiut university hospitals; 🇪🇬 Assiut, Assiut Governorate, Egypt