Aim of this study is comparison of Granisetron and Dexmedetomidine and lidocaine in reduce pain of Etomidate injection. This study is clinical trial and double blind. 132 patients enter in this study. Inclusion criteria: 18 to 50 years; ASA I and II. Exclusion criteria: lack of control blood pressure; history of vascular disease; addiction to opioids; incidence of tromboflebite; diabetes ; chronic pain; history of tumor; burns in two hands; contraindication for injection Granisetron and Dexmedetomidine and Lidocaine. We put a tourniquet on the one arm. We will inflate tourniquet to 250 to 350 millimeter Hg. We will block venous drainage of both two hands. We will divide patients to four groups. We will inject 6 milligram Granisetron (2 milliliter Granisetron in one hand and 2 milliliter Normal saline 0/9 % in other hand simultaneously)in Granisetron group. We will inject 2 milligram Lidocain( 40 milligram Lidocain in one hand and 2 milliliter Normal saline 0/9 % in other hand simultaneously)in Lidocain group. We will inject 5 micro grams (20 milliliter Dexmedetomidine in one hand and 2 milliliter Normal saline 0/9 % in other hand simultaneously) in Dexmedetomidine group. We inject 2 milliliter Normal saline 0/9 % in other hand simultaneously for intervention hand in control group. We will open tourniquet 2 minute after intervention and we will inject 2 milligram Etomidate in two hands simultaneously in all patients. We will record pain in two hands by Visual Analog Scale after inject drugs and 5 minute after inject drugs for all patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122720258N21
Registration date:2017-04-10, 1396/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice challore of Research, Arak University of Medical Scinces
Expected recruitment start date
2016-10-21, 1395/07/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Granisetron and Dexmedetomidine and Lidocaine in reduce Etomidate injection pain in elective surgery
Public title
Comparison of Granisetron and Dexmedetomidine and Lidocaine in reduce Etomidate injection pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 50 years; ASA I and II
Exclusion criteria: lack of control blood pressure; history of vascular disease; addiction to opioids; incidence of thrombolytic; diabetes ; chronic pain; history of tumor; burns in two hands; contra-indicated for injection Granisetron and Dexmedetomidine and Lidocaine
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomize by table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Arak, Sardasht, Basij Square, Payambar Azam Complex, Reaserch Center
City
Arak
Postal code
38149578558
Approval date
2016-10-17, 1395/07/26
Ethics committee reference number
IR.ARAKMU.REC.1395.273
Health conditions studied
1
Description of health condition studied
General surgery
ICD-10 code
Z41.9
ICD-10 code description
Procedure for purposes other than remedying health state, unspecified
Primary outcomes
1
Description
Pain
Timepoint
After injection drug and 5 minute after injection
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We inject 6 milligram Granisetron : we inject 2 milliliter Granisetron in one vein of hand and 2 milliliter Normal saline 0/9 % in other vain of hand simultaneously.
Category
Treatment - Drugs
2
Description
Intervention group: We inject 2 milligram Lidocain: we inject 40 milligram Lidocain in one vein of hand and 2 milliliter Normal saline 0/9 % in other vein of hand simultaneously.
Category
Treatment - Drugs
3
Description
Intervention group: We inject 5 microgram: we inject 20 milliliter Dexmedetomidine in one vein of hand and 2 milliliter Normal saline 0/9 % in other vein of hand simultaneously.
Category
Treatment - Drugs
4
Description
In control group: We inject 2 milliliter Normal saline 0/9 % in other hand simultaneously for intervention hand in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences