The aim of this study is to compare the effect of Clonidine premedication with Fentanyl on hemodynamic changes after endotracheal intubation in opium dependent patients. In this clinical trial, 60 opium dependent patients whom refer to the operating room of 15 Khordad hospital of Gonabad for elective surgery who require endotracheal intubation are randomly assigned into group Fentanyl(1 microgram/kg, 5 min before intubation given intravenously) and Clonidine(3-5 microgram/kg, 60 min before intubation given oraly). Inclusion criteria: Age 18 to 65 years old, opium dependent patients who are candidate for elective surgery under general anesthesia with endotracheal intubation who are in ASA class 1 and 2. Exclusion criteria: Any cardiovascular problems and arrhythmias during intubation, Over once to attempt intubation that may take more than 20 seconds. the outcomes that will be measured is hemodynamic changes(systolic blood pressure, diastolic blood pressure and heart rate) after intubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030516854N1
Registration date:2014-07-11, 1393/04/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-11, 1393/04/20
Registrant information
Name
Ali Reza Talai
Name of organization / entity
Gonabad University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 53 3725 1002
Email address
talai.a@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Gonabad University of Medical Sciences
Expected recruitment start date
2013-10-07, 1392/07/15
Expected recruitment end date
2014-06-05, 1393/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic indices during endotracheal intubation after receiveing Clonidine and Fentanyl premedication in opium dependent patients
Public title
The comparison of effect of clonidine and fentanyl premedication on blood pressure and pulse rate changes in opium depended patient after indotracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 18-65 years old؛ Candidate for elective surgery and those who were in ASA class of 1 and 2؛ The drug-dependent patients based on our definitions؛ No history of other addictive materials such as alcohol and psychoactive drugs؛ ptients should not have any anxiety disorders.
Exclusion criteria:
Any cardiovascular problems and arrhythmias during intubation؛ Over once to attempt intubation that may take more than 20 seconds؛ Any problem during intubation and surgery in which necessary interventions and desired measurements be impossible.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples were randomly divided into two groups of Fentanyl and Clonidine
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical sciences , Dr Mehdizade street , Pardise
City
Gonabad
Postal code
9691793718
Approval date
2014-03-12, 1392/12/21
Ethics committee reference number
gmu.rec.1392.52
Health conditions studied
1
Description of health condition studied
opioid dependency
ICD-10 code
F10
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Systolic blood pressure and diastolic blood pressure
Timepoint
Before intubation, immediately after intubation and 5 minutes after intubation
Method of measurement
Measurement of blood pressure using a mercury sphygmomanometer
2
Description
Heart rate
Timepoint
Before intubation, Immediately after intubation and 5 minutes after intubation
Method of measurement
Radial pulse counting with second time
Secondary outcomes
empty
Intervention groups
1
Description
In the clonidine group, Patients are given oral clonidine with dose of 3 – 5 microgram/kg, 60 minutes before endotracheal intubation.
Category
Treatment - Drugs
2
Description
in the Fentanyl group, Fentanyl 1 microgram/kg is injected intravenously 5 minutes before indotracheal intubation