Olanzapine for the Prevention of Postoperative Nausea and Vomiting

NCT04718727 | Completed Phase 1

• 1 other identifier: IRB: 17300536
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Nausea

Outcome Measures

Primary Outcomes (1)

• nausea and/or vomiting score

  the occurrence of nausea and/or vomiting by nausea score

  first 24 hours postoperative

Study Arms (3)

Group 1

PLACEBO COMPARATOR

patients will receive oral placebo tablets one hour preoperatively

Drug: Placebo

Group 2

ACTIVE COMPARATOR

patients will receive oral 5 mg Olanzapine tablets one hour preoperatively

Drug: 5 mg Olanzapine Tablets

Group 3

ACTIVE COMPARATOR

patients will receive oral 10 mg Olanzapine tablets one hour preoperatively

Drug: 10 mg Olanzapine Tablets

Interventions

Placebo DRUG

oral Placebo tablets one-hour preoperatively

Group 1

5 mg Olanzapine Tablets DRUG

oral 5 mg Olanzapine tablets one-hour preoperatively

Also known as: zyprexa

Group 2

10 mg Olanzapine Tablets DRUG

oral 10 mg Olanzapine tablets one-hour preoperatively

Also known as: zyprexa

Group 3

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amani Hassan Abdel-Wahab: lead

Study Sites (2)

Assiut university hospitals

Asyut, Assiut Governorate, Egypt, 715715, Egypt

Location

Assiut university

Asyut, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Amani H Abdel-wahab, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Model Details: All patients will receive oral 10, 5 mg Olanzapine or placebo one hour preoperative

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 22, 2021
• Study Start: March 15, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)