Granisteron Versus Metoclopramide in Laparoscopic Cholecy... | NCT04899817

Studies
Granisteron Versus Metoclopramide in Laparoscopic Cholecystectomy

NCT04899817

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

May 25, 2021Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Nausea and Vomiting, Postoperative

Interventions

Granisetron

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2021Estimated

Primary Completion Date

Mar 2022Estimated

Completion Date

Apr 2022Estimated

First Submitted Date

Apr 20, 2021

First Submission Date that Met QC Criteria

May 19, 2021

First Posted Date

May 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2021

Last Update Posted Date

May 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group G	Active Comparator	will receive granisteron 1mg after induction of general anesthesia	Drug: Granisetron
Group C	Placebo Comparator	Will receive metoclopramide 10 mg after induction of general anesthesia	Drug: Granisetron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Granisetron	Drug	The drug is given after induction of general anesthesia	Group C Group G

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Layali Dardeer	Contact	01096928662		as0296856@gmail.com

Overall Officials

Name	Affiliation	Role
Eman M Esmail	Assiut University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university hospital		Asyut		71515	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017829	Granisetron

Ancestor Terms

ID	Term
D053961	Azabicyclo Compounds
D001372	Aza Compounds
D009930	Organic Chemicals
D007191	Indazoles

Browse Leaves

Not provided

Browse Branches

Not provided