Back to resultsGranisteron Versus Metoclopramide in Laparoscopic Cholecystectomy
Primary Purpose
Nausea and Vomiting, Postoperative
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Granisetron
Sponsored by
About this trial
This is an interventional prevention trial for Nausea and Vomiting, Postoperative focused on measuring Laparoscopic cholecystectomy
Eligibility Criteria
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
Sites / Locations
- Assiut university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group G
Group C
Arm Description
will receive granisteron 1mg after induction of general anesthesia
Will receive metoclopramide 10 mg after induction of general anesthesia
Outcomes
Primary Outcome Measures
Postoperative nausea and vomitting
Number of attacks of nausea and vomitting
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04899817
Brief Title
Granisteron Versus Metoclopramide in Laparoscopic Cholecystectomy
Official Title
Efficacy and Safety of Granisteron Versus Metoclopramide as Prophylaxis Antiemetic in Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
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
Study aims at comparing the effect of granisteron with that of metoclopramide in patients undergoing lab cholecystectomy
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Postoperative
Keywords
Laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group G
Arm Type
Active Comparator
Arm Description
will receive granisteron 1mg after induction of general anesthesia
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Will receive metoclopramide 10 mg after induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Granisetron
Other Intervention Name(s)
Granitryl
Intervention Description
The drug is given after induction of general anesthesia
Primary Outcome Measure Information:
Title
Postoperative nausea and vomitting
Description
Number of attacks of nausea and vomitting
Time Frame
Every 2 hours for 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Layali Dardeer
Phone
01096928662
Email
as0296856@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman M Esmail
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Layali S Dardeer
Phone
01096928662
Email
as0296856@gmail.com
12. IPD Sharing Statement
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Granisteron Versus Metoclopramide in Laparoscopic Cholecystectomy
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