Aim of this study is comparison added Sulfate Magnesium and Dexmedetomidine to prolongation duration of sensory and motor block in axillary block. This study is clinical trials and double blind.66 patients' candidate surgery in forearm and hand surgery will enter this study. We will divide patients in two groups (Dexmedetomidine and Sulfate Magnesium) randomly. We will inject 0.5 micro grams in kilogram of Dexmedetomidine and Lidocaine 1.5 percent in first group. We will inject 100 milligram of Sulfate Magnesium and Lidocaine 1.5 percent in second group. We will be total volume 30 milliliter in each group. We will record sensory block in every 1 minute by Bromeg scale and motor block in every 5 minute by Bromeg scale. We will record mean arterial blood pressure and heart rate and oxygen saturation every 5 minute in start to end of surgery. We will record amount of narcotic drug in 24 hours after surgery and pain in recovery and 2 hours after surgery by Visual Analog Scale.
Inclusion criteria: ASA class I and II; 18 to 60 years; patients candidate forearm and hand surgery with Axillary block; fracture in forearm and hand
Exclusion criteria: infection in area of block; failure in block; surgical time more than 120 minutes; requires sedation needed more
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041920258N38
Registration date:2017-06-21, 1396/03/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-21, 1396/03/31
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 Chancellor for Research, Arak University of Medical Sciences
Expected recruitment start date
2017-03-01, 1395/12/11
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of added Sulfate Magnesium and Dexmedetomidine for prolongation of the duration of sensory and motor block in axillary block
Public title
Effect of sulfate Magnesium and Dexmedetomidine in duration of sensory and motor block in Axillary block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I and II; 18 to 60 years; patients candidate forearm and hand surgery with Axillary block; fracture in forearm and hand; lack of coagulation disorders; lack of psychological problems; don't pregnant women ;don't history of allergy to drugs; lack of chronic pain syndrome; lack of neurological disorders in hands; body mass index less than 35
Exclusion criteria: more than one fracture in body and more than one surgery; uncooperative patients for block; infection in area of block; failure in block; surgical time more than 120 minutes; sedation needed more than rates in study
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2017-02-27, 1395/12/09
Ethics committee reference number
IR.ARAKMU.REC.1395.429
Health conditions studied
1
Description of health condition studied
fracture in forearm
ICD-10 code
S52
ICD-10 code description
Fracture of forearm
2
Description of health condition studied
fracture in hand
ICD-10 code
S62
ICD-10 code description
Fracture at wrist and hand level
Primary outcomes
1
Description
Sensory block
Timepoint
every 1 minute
Method of measurement
Bromeg scale
2
Description
Motor block
Timepoint
every 5 minute
Method of measurement
Bromeg scale
3
Description
Heart rate
Timepoint
Every 15 minute to recovery
Method of measurement
count
4
Description
mean arterial pressure
Timepoint
Every 15 minute to recovery
Method of measurement
Mercury sphygmomanometer
5
Description
oxygen saturation
Timepoint
Every 15 minute to recovery
Method of measurement
pulse oximetry
6
Description
Pain
Timepoint
recovery and 4 hours after surgery
Method of measurement
Visual Analogue Scale Questionnaire
7
Description
mean of narcotic
Timepoint
24 hour after surgery
Method of measurement
miligeram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:We will inject 0.5 micro gram in kilogram of Dexmedetomidine and Lidocaine 1.5 percent in first group .
Category
Treatment - Drugs
2
Description
Intervention group 2: We will inject 100 milligram of Sulfate Magnesium and Lidocaine 1.5 percent in second group.