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Completed

NCT Number: NCT04718727

Olanzapine for the Prevention of Postoperative Nausea and Vomiting

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Assiut university hospitals, Asyut, Assiut Governorate, Egypt

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

oral Placebo tablets one-hour preoperatively

5 mg Olanzapine Tablets

Drug

oral 5 mg Olanzapine tablets one-hour preoperatively

Other names: zyprexa

10 mg Olanzapine Tablets

Drug

oral 10 mg Olanzapine tablets one-hour preoperatively

Other names: zyprexa

Primary outcomes

  1. nausea and/or vomiting score

    Time frame: first 24 hours postoperative

    the occurrence of nausea and/or vomiting by nausea score

Sponsors and collaborators

Lead sponsor

Amani Hassan Abdel-Wahab

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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