Comparison of Anesthesia effects with isoflurane and propofol on postoperative shivering in patients undergoing rhinoplasty surgery in Imam Khomeini Hospital, Ahwaz in 1390
In a clinical trial, double-blind 70 patients 18 to 65 years with ASA I or II that undergoing rhinoplasty surgery were studied with approval of the ethics committee. After informed consent was given, patients
were randomly allocated into two groups according to a table of random numbers. Patients were randomized assign to two groups receiving propofol(n=35) and isoflurane(n=35). Inclusion criteria were elective rhinoplasty surgery,in the range of 18-65 years old and duration of surgery between1-3 hours.
Exclusion criteria included emergency surgery, history of seizures, a history of Parkinson's or any other disease that can cause shivering. History of amphetamine drugs or sedatives, history of alcohol or drug addiction, blood transfusion or blood products during anesthesia, consumption of vasoactive drugs during anesthesia and existence of active infection prior to anesthesia.
The tympanic membrane temperature, taken to present core temperature. The room temperature was kept constant too. The minute ventilation was adjusted to maintain an end-tidal carbon dioxide concentration of 35 to 45 mmHg. At the end of the operation all anesthetic gases were closed and residual paralysis was reversed with atropine 0/02 mg/kg and neostigmine 0/05 mg/kg. After anesthesia shivering in patients with visual assessment scale shivering was measured by a trained.
Since the patient wake up an hour later the occurrence and classify of shivering were assessed by one of the investigators who was unaware of the anesthetic agent given to the patient. If grade 3 or 4 had the shivering, the patient was treated with intravenous pethidine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112178443N1
Registration date:2012-05-17, 1391/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-17, 1391/02/28
Registrant information
Name
Mostafa Fatahi
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1421 3103
Email address
fatahi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2012-01-05, 1390/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Anesthesia effects with isoflurane and propofol on postoperative shivering in patients undergoing rhinoplasty surgery in Imam Khomeini Hospital, Ahwaz in 1390
Public title
Effects of Isoflurane and Propofol on postoperative shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Rhinoplasty surgery؛ in the range of 18-65 years old؛ duration of surgery between1-3 hours.
Exclusion criteria: Emergency surgery؛ history of seizures؛ a history of Parkinson's or any other disease that can cause shivering؛ History of amphetamine drugs or sedatives؛ history of alcohol or drug addiction؛ blood transfusion or blood products during anesthesia؛ consumption of vasoactive drugs during anesthesia؛ existence of active infection prior to anesthesia
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz, Bulvar Golestan
City
Ahvaz
Postal code
6135833777
Approval date
2012-03-04, 1390/12/14
Ethics committee reference number
eth.s-001
Health conditions studied
1
Description of health condition studied
Post operative shivering
ICD-10 code
t88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Shivering
Timepoint
Post operative
Method of measurement
Visual assessment scale
Secondary outcomes
1
Description
time of shivering
Timepoint
post operative
Method of measurement
observation
Intervention groups
1
Description
first group drug propofol Intravenously during the operation (mg/kg/h 10-5)
Category
Treatment - Drugs
2
Description
second group Isoflurane inhaled during the operation with a maintenance dose 0.5%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mr sakhaee
Street address
farhangshahr
City
ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
mohandes oraki
Street address
Commite Tahghighati Daneshjuee
City
Ahvaz
Grant name
2500000
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Fatahi
Position
Student/Liciense
Other areas of specialty/work
Street address
Golestan Blvd Sadaf Resort
City
Ahvaz
Postal code
6135833777
Phone
+98 61 1422 1516
Fax
+98 61 1422 1516
Email
mostafafatahi777@gmail.comfatahi.m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur Medical of Scienses
Full name of responsible person
Mostafa Fatahi
Position
Student/Lisence
Other areas of specialty/work
Street address
Golestan Blvd
City
Ahvaz
Postal code
6135833777
Phone
+98 61 1422 1516
Fax
+98 61 1422 1516
Email
mostafafatahi777@gmail.comfatahi.m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur Medical of Sciences
Full name of responsible person
Mostafa Fatahi
Position
Student/Lisence
Other areas of specialty/work
Street address
Golestan Blvd
City
Ahvaz
Postal code
6135833777
Phone
+98 61 1422 1516
Fax
+98 61 1422 1516
Email
mostafafatahi777@gmail.comfatahi.m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)