Olanzapine for the Prevention of Postoperative Nausea and Vomiting

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04718727

Enrollment

132

Registered

2021-01-22

Start date

2021-03-15

Completion date

2023-02-01

Last updated

2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea

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

Interventions

DRUG10 mg Olanzapine Tablets

oral 10 mg Olanzapine tablets one-hour preoperatively

DRUGPlacebo

oral Placebo tablets one-hour preoperatively

DRUG5 mg Olanzapine Tablets

oral 5 mg Olanzapine tablets one-hour preoperatively

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
nausea and/or vomiting score	first 24 hours postoperative	the occurrence of nausea and/or vomiting by nausea score

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026