A comparison of two oral drugs clonidine and tramadol on post spinal shivering anesthesia in patients undergoing transureteral lithotripsy (TUL) referred to Shahid Hashemi Nejad hospital in 2016-2017
Shivering (Post anesthetic shivering) is a common complication of modern anesthesia and cause complications in the body. The doctor has a duty to keep patient`s body temperature in normal range during surgery. Meperidine is the most widely used drugs for the treatment of PAS.But because of adverse effects, its use has been banned in many medical centers around the world.
Many medical studies is ongoing to find a best alternative medicine in this area.In this study, we aimed to compare the effect of oral clonidine and tramadol in preventing post spinal anesthesia shivering.
This study is a clinical trial study,80 patients undergoing elective surgery under spinal anesthesia and TUL are being studied And randomly divided into two groups of T and C.Group T receive Tramadol tab 50 mg and group C clonidine tab 100microgram 90 minute before surgery.
All patients in terms of temperature and amount of drug and fluid temperatures are in the same condition.Body and tympanic membrane temprachure will be recorded every 10 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031432017N2
Registration date:2017-05-20, 1396/02/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-20, 1396/02/30
Registrant information
Name
Mahmoud Reza Mohaghegh Dolat Abadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 140 6348
Email address
mohaghegh.mr@moheb.com
Recruitment status
Recruitment complete
Funding source
The researcher subscribe the budget because this study costs a little money
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of two oral drugs clonidine and tramadol on post spinal shivering anesthesia in patients undergoing transureteral lithotripsy (TUL) referred to Shahid Hashemi Nejad hospital in 2016-2017
Public title
To evaluate the efficacy of clonidine and tramadol in preventing post spinal anesthesia shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA 1 and 2 patients who underwent spinal anesthesia for elective TUL. Patients who consent to have spinal anesthesia without any local or general infection, heart disease, bradycardia or left ventricular disfunction, kidney, liver disease, seizures, coagulopathy. Patients with BMI <30 with any history of sensitivity or allergy to clonidine and tramadol or history of addiction.
Exclusion criteria: Patients who fail their spinal anesthesia or their spinal anesthesia being off during surgery and underwent general anesthesia or are not satisfied to participate in the study for any reason.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Besides Milad Tower, Hemmat highway
City
Tehran
Postal code
1449614535
Approval date
2016-05-24, 1395/03/04
Ethics committee reference number
IR.IUMS.REC 1395.9311174020
Health conditions studied
1
Description of health condition studied
Hypothermy due to anaesthesia
ICD-10 code
T88.5
ICD-10 code description
Hypothermy due to anaesthesia
Primary outcomes
1
Description
Peripheral temprature
Timepoint
Every 10 minutes up to 120 min later
Method of measurement
Digital thermometer in Centigrade from forehead
2
Description
Core temprature
Timepoint
Every 10 minutes up to 120 min later
Method of measurement
Digital thermometer in Centigrade from tympanic membrane erea
3
Description
Blood pressure
Timepoint
Every 10 minutes up to 120 min later
Method of measurement
NIBP with digital monitoring in operation room
4
Description
Heart rate
Timepoint
Every 10 minutes up to 120 min later
Method of measurement
With digital monitoring in operation room
5
Description
Shivering
Timepoint
Every 10 minutes up to 120 min later
Method of measurement
Seeing based on Mahajan category
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group oral Clonidine 100 with 50 cc of water 90 minutes before spinal anesthesia
Category
Treatment - Drugs
2
Description
Second intervention group Tramadol tablets 50 mg orally with 50 cc of water 90 minutes before spinal anesthesia