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Granisteron Versus Metoclopramide in Laparoscopic Cholecystectomy

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04899817
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Efficacy and Safety of Granisteron Versus Metoclopramide as Prophylaxis Antiemetic in Laparoscopic Cholecystectomy
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative nausea and vomitting [Every 2 hours for 12 hours]

      Number of attacks of nausea and vomitting

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university hospital Assiut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Eman M Esmail, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lyali Salah Dardeer, Assistant lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04899817
    Other Study ID Numbers:
    • Antiemetics in lab cholecystec
    First Posted:
    May 25, 2021
    Last Update Posted:
    May 25, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lyali Salah Dardeer, Assistant lecturer, Assiut University
    Laparoscopic cholecystectomy
    Additional relevant MeSH terms:
    Vomiting
    Postoperative Nausea and Vomiting
    Granisetron

    Study Results

    No Results Posted as of May 25, 2021