The purpose of the study is to compare different doses effect of granisetron with lidocaine for intravenous regional anesthesia. Plan: randomized, double blind, without placebo, phase III clinical trial. .Inclusion criteria: age of 20 to 50, ASA I or II Exclusion criteria: Drug allergy history, Pregnancy, contraindication of intravenous regional anesthesia like sickle cell anemia. Target sample size: 210. Interventions: control group will take 3 mg/kg lidocaine 0.5 %diluted to saline 0.9% will infuse over 90 seconds. Second group will take 3mg/kg lidocaine 0.5% with 1 mg granisetron diluted to saline 0.9% will infuse over 90 seconds. Third group will take 3 mg/kg lidocaine 0.5% with 2 mg granisetron diluted to saline 0.9% will infuse over 90 seconds. Primary outcome: reduction in tourniquet pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091214056N4
Registration date:2014-09-23, 1393/07/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-23, 1393/07/01
Registrant information
Name
Hesameddin Modir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 9680
Email address
he_modir@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2014-05-06, 1393/02/16
Expected recruitment end date
2015-07-07, 1394/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic effect of different doses of granisetron with lidocaine for intravenous regional anesthesia
Public title
Analgesic effect of different doses of granisetron with lidocaine for intravenous regional anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 to 50 years old; ASA I or II.
Exclusion criteria: history of drug allergy; pregnancy; contraindication of intravenous regional anesthesia like sickle cell anemia; use of opiate and analgesic drugs; use of Apomorphine.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
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
Ethical committee of Arak University of Medical Sciences
Street address
Arak University Of Medical Science, Basij Square
City
Arak
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
7- 163- 93
Health conditions studied
1
Description of health condition studied
Regional anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Tourniquet pain
Timepoint
0, 15, 30 and 45 minute after injection
Method of measurement
VAS
Secondary outcomes
1
Description
Reduction of pain
Timepoint
Every 30 minutes until 2 hours after removing tourniquet
Method of measurement
VAS
2
Description
Vital signs
Timepoint
After removing tourniquet
Method of measurement
Physical examination
3
Description
O2 saturation
Timepoint
After removing tourniquet
Method of measurement
Pulse oxymeter
4
Description
Need to Fentanyl
Timepoint
0, 15, 30 and 45 min after injection
Method of measurement
Drug dose that is used
Intervention groups
1
Description
Intervention group will take 3 mg/kg lidocaine 0.5% with 1 mg granisetron diluted to 40 cc saline 0.9% will infuse over 90 seconds.
Category
Treatment - Drugs
2
Description
Control group will take 3 mg/kg lidocaine 0.5% diluted to 40 cc saline 0.9% will infuse over 90 seconds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Hesameddin Modir
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr Saeed Changizi Ashtiani
Street address
Arak University Of Medical Science, Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Vice chancellor for research
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
Vali-e-Asr hospital
Full name of responsible person
Hesameddin Modir
Position
Anesthesiologist/ Assistant Professor
Other areas of specialty/work
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak.
City
Arak
Postal code
Phone
+98 86 3223 1104
Fax
Email
he_modir@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vali-e-Asr hospital
Full name of responsible person
Hesameddin Modir
Position
Anesthesiologist/ Assistant Professor
Other areas of specialty/work
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak.
City
Arak
Postal code
Phone
+98 86 3223 1104
Fax
Email
he_modir@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vali-e-Asr hospital
Full name of responsible person
Hesameddin Modir
Position
Anesthesiologist/ Assistant Professor
Other areas of specialty/work
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak.
City
Arak
Postal code
Phone
+98 86 3223 1104
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)