Olanzapine for the Prevention of Postoperative Nausea and Vomiting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2023-02-01

Brief Summary

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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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Detailed Description

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

Conditions

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Postoperative Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

patients will receive oral placebo tablets one hour preoperatively

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral Placebo tablets one-hour preoperatively

Group 2

patients will receive oral 5 mg Olanzapine tablets one hour preoperatively

Group Type ACTIVE_COMPARATOR

5 mg Olanzapine Tablets

Intervention Type DRUG

oral 5 mg Olanzapine tablets one-hour preoperatively

Group 3

patients will receive oral 10 mg Olanzapine tablets one hour preoperatively

Group Type ACTIVE_COMPARATOR

10 mg Olanzapine Tablets

Intervention Type DRUG

oral 10 mg Olanzapine tablets one-hour preoperatively

Interventions

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Placebo

oral Placebo tablets one-hour preoperatively

Intervention Type DRUG

5 mg Olanzapine Tablets

oral 5 mg Olanzapine tablets one-hour preoperatively

Intervention Type DRUG

10 mg Olanzapine Tablets

oral 10 mg Olanzapine tablets one-hour preoperatively

Intervention Type DRUG

Other Intervention Names

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zyprexa zyprexa

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No