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Effect of diphenhydramine and granisetron on the prevention of postoperative nausea and vomiting and pain after laparoscopic cholecystectomy

Protocol summary

Study aim
The effect of diphenhydramine and granisetron on the prevention of postoperative nausea and vomiting and pain after laparoscopic cholecystectomy.
Design
A total of 120 patients will be selected based on studies and statistical calculations that meet the inclusion criteria after surgery and the patient is discharged from anesthesia and then divided into two groups of intervention and control. The intervention group will receive granisetron and the control group will receive diphenhydramine. The study is a randomized, double-blind, placebo-controlled clinical trial.
Settings and conduct
The study will be conducted at the recovery ward of Tabriz Imam Reza Hospital.In the intervention group,immediately after extubation,Granisetron will be injected at a dose of 3mg interavenously and in the control group,Diphenhydramin will be injected at a dose of 50mg.Then the variables of nausea,vomiting and pain will be reviewed and recorded in both groups by anethesiologist.Postoperative nausea and vomiting will be reviewed and recorded at recovery at 3,6 and 24 hours after operation based on scores(0=no nausae and vomiting, 1=nausea,2=vomiting,3=vomiting more than 2times).Pain severity at 5,10,15,20 seconds after injection will be evaluated by four digit verbal rating scale.In this study both patiants and anesthesiologist are blinded.
Participants/Inclusion and exclusion criteria
Entrance: All of Patients who Being a Candidate for Elective Surgery and Based on ASA Classification are 1 or 2 ASA Class. Exit: Patients under Prescription of anti-nausea Drugs in the last 24 hours; Patients with Cardiovascular, Hepatic , Kidney ,blood pressure and hyperadiposis Disease; pregnant women and during menstruation .
Intervention groups
Granisetron will be used in the intervention group and Diphenhydramine will be used in the control group
Main outcome variables
Severity of pain Severity of nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150125020795N7
Registration date: 2019-11-11, 1398/08/20
Registration timing: registered_while_recruiting

Last update: 2019-11-11, 1398/08/20
Update count: 0
Registration date
2019-11-11, 1398/08/20
Registrant information
Name
Samad Golzari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 6183
Email address
golzaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of diphenhydramine and granisetron on the prevention of postoperative nausea and vomiting and pain after laparoscopic cholecystectomy
Public title
Effect of diphenhydramine and granisetron on the prevention of postoperative nausea and vomiting and pain after laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All of Patients at age of 18 to 59 who Being a Candidate for Elective Surgery and Based on ASA Classification are 1 or 2 ASA Class.
Exclusion criteria:
Patients under Prescription of anti-nausea Drugs in the last 24 hours. Patients with Cardiovascular, Hepatic , Kidney ,blood pressure and hyperadiposis Disease pregnant women and during menstruation
Age
From 18 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling is done by easy burst method and according to patient referral to operating room. Randomization method is pre and post accidental blocks and will be done by Randlist software.
Blinding (investigator's opinion)
Double blinded
Blinding description
All of Patients do not Know about used Drugs in this Study. and the anesthesiologist who evaluated clinical response to administerated drugs.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculity of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.TBZMED.REC.1398.431

Health conditions studied

1

Description of health condition studied
Postoperative nausea and vomiting
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

2

Description of health condition studied
Postoperative pain
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
Severity of postoperative nausea and vomiting
Timepoint
Recovery and at 3, 6, and 24 h postoperatively
Method of measurement
scoring by (0=non, 1=nausea, 2=vomiting, 3=vomiting >2 times)

Secondary outcomes

1

Description
Severity of pain after injection of diphenhydramine and granisetron
Timepoint
Amount of pain evaluate on 5, 10, 15 and 20 seconds after injection of diphenhydramine and granisetron
Method of measurement
Four Numerical Verbal Rating Scale

Intervention groups

1

Description
Intervention group: Group 1, will recieve 3 mg IV granisetron before induction of anesthesia
Category
Treatment - Drugs

2

Description
Control group: Group 1, will recieve50 mg IV diphenhydramine before induction of anesthesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Samad Eslaam Jamal Golzari
Street address
Department of Anesthesiology, Faculty of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Joyban
Street address
Vice chancellor for research, ِDaneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified IPD, IPD collected for the primary outcome measure are to be shared
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data .
From where data/document is obtainable
Dr .Samad Eslam Jamal Golzari, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran Phone+98 413 3341994 Fax+98 41 33341994 golzaris@tbzmed.ac.ir
What processes are involved for a request to access data/document
Correspondence through email only
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