Etomidate is one of the intravenous anesthetic agents that causes pain on injection site. In this study the effect of Granisetron and Lidocaine on reducing the pain on injection of Etomidate was compared. 30 patients of both sexes, aged between 25-60 years, who were candidate for elective laparoscopic cholecystectomy, and requiring more than one intravenous access lines were enrolled in this study. On arrival to the operating room, two 20 gauge cannulas were inserted into the veins on the dorsum of both hands of all patients, using an elastic band as a tourniquet, venous drainage of both hands was occluded. 2 ml Lidocaine was administerd into one hand and 2 ml Granisetron at the same time into the other hand. One minute later the elastic band was opened and 2mg (1 ml) Etomidate at the same rate administerd to each hand. The patients were asked to give a score from 0 to 10 to each hand. (0= no pain, 10= severe pain)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411025175N19
Registration date:2014-12-07, 1393/09/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-07, 1393/09/16
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
2014-11-09, 1393/08/18
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Granisetron and Lidocaine on reducing the pain on injection of Etomidate: a double blind clinical trial.
Public title
Reducig pain on Injection of IV drug
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status class I or II; age between 25-60, patients who were candidated for elective laparoscopic cholecystectomy; consent of patients and filling an informed written consent; patients without a history of thrombophlebitis or vascular disease, chronic pain; diabetes mellitus; not to be addicted.
Exclusion criteria: If patient can not corporate because excess level of sedation; unsuccessful intravenous catheterization, dispensing with participation in study; any drugs taken other than what prescribed in protocol.
Age
From 25 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comittee, Faculty of Medicine of Tehran ,University of Medical Sciences
Street address
Second floor, Faculty of Medicine, Tehran University of Medical Sciences and Health Services, Poorsina St, Ghods Ave, Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Approval date
2014-02-20, 1392/12/01
Ethics committee reference number
4531/250
Health conditions studied
1
Description of health condition studied
The effect of Granisetron and Lidocaine on reducing the pain on injection of Etomidate in patients under elective laparoscopic cholecystectmy.
ICD-10 code
T80.9
ICD-10 code description
Unspecified complication following infusion, transfusion and therapeutic injection
Primary outcomes
1
Description
Pain
Timepoint
2 minutes after injection
Method of measurement
Numeric Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: 2 mL of Lidocaine was administerd to a vein on dorsum of one hand and one minute later the elastic band was opened and 2mg (1 ml) Etomidate at the same rate was administerd.
Category
Prevention
2
Description
Intervention 2: 2ml of Granisetron was administered to a vein on dorsum of the other hand at the same time and one minute later the elastic band was opened and 2mg (1 ml) Etomidate at the same rate was administerd.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Street address
Dr. Shariati Hospital, North Karegar Ave, Jalale Ale Ahmad Hwy, Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Street address
Vice Chancellor for research , 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
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Street address
Vice Chancellor for research , 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
Proportion provided by this source
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
Dr. Shariati Hospital
Full name of responsible person
Dr. Ali Movafegh
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Dr. Shariati Hospital, North Karegar Ave, Jalale Ale Ahmad Hwy, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology, Dr. Shariati Hospital
Full name of responsible person
Dr. Ali Movafegh
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Dr.Shariati Hospital, North Karegar Ave, Jalale Ale Ahmad Hwy, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dr. Shariati Hospital
Full name of responsible person
Maryam Abdolahpour
Position
General Physician
Other areas of specialty/work
Street address
Dr. Shariati Hospital, North Karegar Ave, Jalale Ale Ahmad Hwy, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8822 0032
Fax
Email
maryam.md86@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)