Protocol summary

Summary
The purpose of this investigation is the assessment of the effect of Granisetron on pain of Propofol injection. This investigation is a double-blinded randomized clinical trial on 30 patients between ages 20 and 50 years of both genders who have ASA Class 1, 2 and are candidates for elective laparoscopic cholecystectomy. In the cases of past medical history of neurological diseases, chronic pain syndrome, thrombophlebitis, advanced systemic disease such as advanced diabetes, any vascular disease and contraindications of Granisetron or Propofol, the patients will be excluded. Neither the patients nor the interventionist were aware whether the solution injected in each hand is Granisetron or placebo. A 22 gauge cannula will be inserted in the dorsal vein of each hand. One hundred ml normal saline is infused over 10 minutes through each cannula. Venous drainage will be occluded by tourniquet. The patients receive 2ml (2mg) Granisetron via one cannula and 2ml normal saline through the other cannula on the opposite hand simultaneously. The tourniquets are then removed and 2ml Propofol will be infused with the same infusion rate in both hands. The patients will be inquired about pain or discomfort at the injection site and the pain will be scored based on Numeric Rating Scale. Verbal answers or behavioral signs (such as facial changes, arm withdrawal, tearing …) will all be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201404095175N12
Registration date: 2014-05-08, 1393/02/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-08, 1393/02/18
Registrant information
Name
Ali Movafegh
Name of organization / entity
Dr. Shariati Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2373
Email address
movafegh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-04-19, 1393/01/30
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized double-blinded clinical trial: The effect of Granisetron on pain of Propofol injection in patients candidate for elective laparoscopic cholecystectomy
Public title
The effect of Granisetron on pain of Propofol injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Ages between 20 and 50; ASA class 1, 2; Candidate for elective laparoscopic cholecystectomy Exclusion criteria: Past medical history of neurological disease; Chronic pain syndrome; Thrombophlebitis; Advanced systemic disease such as advanced diabetes; Any vascular disease; Any contraindication for Granisetron or Propofol injection
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Medicine, Tehran University of Medical Sciences
Street address
Faculty of Medicine, Tehran University of Medical Sciences and Health Care
City
Tehran
Postal code
Approval date
2013-08-21, 1392/05/30
Ethics committee reference number
92/د/130/1070

Health conditions studied

1

Description of health condition studied
Relation between elective laparoscopic cholecystectomy pain Propofol injection in patients candidate for and Granisetron
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain intensity
Timepoint
During injection
Method of measurement
Numeric Rating Scale mentioned by the patient

Secondary outcomes

1

Description
Postoperative Nausea and Vomiting
Timepoint
In the recovery room
Method of measurement
Nausea and vomiting expressed by the patient

Intervention groups

1

Description
Control group (30 hands) which receive normal saline before Propofol injection.
Category
Placebo

2

Description
Intervention group (30 hands) which receive Granisetron before Propofol injection.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, Anesthesiology Department
Full name of responsible person
Dr. Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
North Kargar Avenue, Dr. Shariati Hospital
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2397
Fax
Email
movafegh@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, Anesthesiology Department
Full name of responsible person
Dr. Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
North Kargar Avenue, Dr. Shariati Hospital
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2397
Fax
Email
movafegh@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences, Anesthesiology Department
Full name of responsible person
Dr. Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
North Kargar Avenue, Dr. Shariati Hospital
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2397
Fax
Email
movafegh@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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