Comparison of the effect of Dexmedetomidine and Remifentanil on controlling hypotension during rhinoplasty
Design
This study is clinical trial and double blind.60 patients candidate rhinoplasty in Amirkabir Hospital in Arak will be entered in this study. We will divide patients in 2 groups by simple randomization.Groups are parallel.
Settings and conduct
This study is clinical trial and double blind. 60 patients candidate for rhinoplasty in Amirkabir Hospital in Arak will be entered in this study. Outcome assessor and analyzer and participants will not be aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:all patients with rhinoplasty referring to Amir Kabir Hospital in Arak, patients aged 18 to 50 years, patients with ASA Class I and II, all patients undergo surgery by one surgeon, the operating time is between 90 to 180 minutes
Exclusion criteria:patients with ASA Classes 3 and 4 , patients who have allergies to dexmedetomidine or remifentanil
Intervention groups
For patients in first group , we will infuse 0.5 micro grams per kilogram in 1 hour Dexmedetomidine and for the second group, infuse 50-100 micro grams per kilogram in 1 hour of Remifentanil.
Main outcome variables
Mean of blood pressure, mean of pulse rate, mean of bleeding score, mean recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190410043231N1
Registration date:2019-07-13, 1398/04/22
Registration timing:retrospective
Last update:2019-07-13, 1398/04/22
Update count:0
Registration date
2019-07-13, 1398/04/22
Registrant information
Name
Farzane Farmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3882 6802
Email address
f.farmani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-27, 1398/02/07
Expected recruitment end date
2019-06-28, 1398/04/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Dexmedetomidine and Remifentanil of induce controlled hypotension during rhinoplasty
Public title
Comparing the effect of Dexmedetomidine and Remifentanil for induction of controlled hypotension during rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with rhinoplasty referring to Amir Kabir Hospital in Arak
Patients aged 18 to 50 years
Patients with ASA class I and II
All patients undergo surgery by a surgeon
Operating time is between 90 to 180 minutes
Exclusion criteria:
Patients outside the age range of 18 to 50 years
Patients with ASA classes 3 and 4
Patients who have allergies to Dexmedetomidine or Remifentanil
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with envelopes in three groups A and B and C.
In this method, some cards will be signed as intervention group1 and the same number of cards for intervention group 2 and the same number of cards for the control group, then the cards will be mixed. One card will be taken out and its group name will be registered and then card will be returned to the container again. Then the cards will be mixed again and another card will be taken. This process will be continued to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer and participant will be blind (double blind). Outcome assessor and analyzer and participants will not be aware from grouping.The person evaluating the outcome will be unaware of the grouping. Definition of groups A and B will be available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij Squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-08-19, 1397/05/28
Ethics committee reference number
IR.ARAKMU.REC.1397.137
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean arterial pressure
Timepoint
At 15, 30, 45, 60, 90, and 120 minutes after the start of operation
Method of measurement
Barometer
2
Description
Mean of pulse rate
Timepoint
At 15, 30, 45, 60, 90, and 120 minutes after the start of operation
Method of measurement
Pulse rate counts
3
Description
Mean of recovery time
Timepoint
Recovery
Method of measurement
Record time in recovery book
4
Description
Mean of bleeding score
Timepoint
At 15, 30, 45, 60, 90, and 120 minutes after the start of operation
Method of measurement
Suction and observation of blood gas
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Dexmedetomidine, 0.5 micro grams per kilogram per hour for infusion during surgery
Category
Treatment - Drugs
2
Description
Intervention group 2: Remifentanil 50 to100 micro grams per kilogram per hour for infusion during surgery