Granisteron Versus Metoclopramide in Laparoscopic Cholecystectomy

May 19, 2021 updated by: Lyali Salah Dardeer, Assiut University

Efficacy and Safety of Granisteron Versus Metoclopramide as Prophylaxis Antiemetic in Laparoscopic Cholecystectomy

Study aims at comparing the effect of granisteron with that of metoclopramide in patients undergoing lab cholecystectomy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Post operative nausea and vomitting is Avery common complication of laparoscopic surgery in that study we will compare between granisteron and metoclopramide as aprophlaxis against post operative nausea and vomitting

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • both sexes Age between 18 and 60 years ASA1 2 3 Lap cholecystectomy under general anesthesia

Exclusion Criteria:

  • patients refusal Pregnancy and breastfeeding Hepatic or renal disease ASA4 5 Allergy to the drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group G
will receive granisteron 1mg after induction of general anesthesia
Drug: Granisetron
The drug is given after induction of general anesthesia
Other Names:
  • Granitryl
Placebo Comparator: Group C
Will receive metoclopramide 10 mg after induction of general anesthesia
Drug: Granisetron
The drug is given after induction of general anesthesia
Other Names:
  • Granitryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomitting
Time Frame: Every 2 hours for 12 hours
Number of attacks of nausea and vomitting
Every 2 hours for 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Eman M Esmail, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antiemetics in lab cholecystec

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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