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Olanzapine for the Prevention of Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Placebo
5 mg Olanzapine Tablets
10 mg Olanzapine Tablets
Sponsored by
Amani Hassan Abdel-Wahab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Assiut university hospitals
  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

patients will receive oral placebo tablets one hour preoperatively

patients will receive oral 5 mg Olanzapine tablets one hour preoperatively

patients will receive oral 10 mg Olanzapine tablets one hour preoperatively

Outcomes

Primary Outcome Measures

nausea and/or vomiting score
the occurrence of nausea and/or vomiting by nausea score

Secondary Outcome Measures

Full Information

First Posted
January 17, 2021
Last Updated
March 7, 2023
Sponsor
Amani Hassan Abdel-Wahab
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1. Study Identification

Unique Protocol Identification Number
NCT04718727
Brief Title
Olanzapine for the Prevention of Postoperative Nausea and Vomiting
Official Title
Olanzapine for the Prevention of Postoperative Nausea and Vomiting After Laparoscopic Surgery in High-risk Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amani Hassan Abdel-Wahab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
All patients will receive oral 10, 5 mg Olanzapine or placebo one hour preoperative
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
patients will receive oral placebo tablets one hour preoperatively
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
patients will receive oral 5 mg Olanzapine tablets one hour preoperatively
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
patients will receive oral 10 mg Olanzapine tablets one hour preoperatively
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral Placebo tablets one-hour preoperatively
Intervention Type
Drug
Intervention Name(s)
5 mg Olanzapine Tablets
Other Intervention Name(s)
zyprexa
Intervention Description
oral 5 mg Olanzapine tablets one-hour preoperatively
Intervention Type
Drug
Intervention Name(s)
10 mg Olanzapine Tablets
Other Intervention Name(s)
zyprexa
Intervention Description
oral 10 mg Olanzapine tablets one-hour preoperatively
Primary Outcome Measure Information:
Title
nausea and/or vomiting score
Description
the occurrence of nausea and/or vomiting by nausea score
Time Frame
first 24 hours postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amani H Abdel-wahab, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
State/Province
Assiut Governorate
ZIP/Postal Code
Egypt, 715715
Country
Egypt
Facility Name
Assiut university
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Olanzapine for the Prevention of Postoperative Nausea and Vomiting

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