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NCT04718727 Clinical Trial

Olanzapine for the Prevention of Postoperative Nausea and Vomiting

Postoperative Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04718727
Other study ID # IRB: 17300536
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 15, 2021
Est. completion date February 1, 2023

Study information
Verified date March 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date February 1, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
oral Placebo tablets one-hour preoperatively
• 5 mg Olanzapine Tablets
oral 5 mg Olanzapine tablets one-hour preoperatively
• 10 mg Olanzapine Tablets
oral 10 mg Olanzapine tablets one-hour preoperatively

Locations
Country Name City State
Egypt Assiut university Assiut
Egypt Assiut university hospitals Assiut Assiut Governorate

Sponsors (1)
Lead Sponsor Collaborator
Amani Hassan Abdel-Wahab

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary nausea and/or vomiting score the occurrence of nausea and/or vomiting by nausea score first 24 hours postoperative
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