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
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Vomiting

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