Comparing the effect of moderate hypothermia and normothermia
on the dosage of anesthetic medication and recall of anesthesia in drug-addicted patients undergoing coronary artery bypass surgery.
Objective: Comparing the effect of moderate hypothermia and normothermia
on the dosage of anesthetic medication and recall in drug-addicted patients undergoing coronary artery bypass surgery.
Design: Randomized, Double blind, Target sample size: 80 People
The major inclusion criteria: Patients between 30 and 70 years old with opium addiction who are candidate for elective coronary bypass on-pump surgery.
The major exclusion criteria: History of previous anesthesia for cardiac surgery; American Society of Anaesthesiologists physical status classification more than 4, History of alcohol consumption; History of addiction to opium; History of long-term use of psychotropic drugs or tranquilizers.
Intervention group: Hypothermia conditions, after aortic cannulation by cardiopulmonary bypass pump, body is slowly cooled till (28-32 ° C)
Control group: Normothermia conditions, at the end of surgery patient's body temperature is warmed till (36 Centigrade) by blanket under patient.
Primary outcome measure: The total amount of medication (Fentanyl and Propofol) and additional medication to achieve the desired depth of anesthesia (40-60), During surgery and at the time of extubation, clinical check list by researchers; Awareness during anesthesia, 24 hour after extubation by questionnaire with open questions
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050513159N5
Registration date:2014-06-23, 1393/04/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-23, 1393/04/02
Registrant information
Name
Shima Sheybani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7230
Email address
sheybanish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2014-05-03, 1393/02/13
Expected recruitment end date
2015-05-03, 1394/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of moderate hypothermia and normothermia
on the dosage of anesthetic medication and recall of anesthesia in drug-addicted patients undergoing coronary artery bypass surgery.
Public title
The effect of moderate hypothermia on the dosage of anesthetic medication and recall of anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
The major inclusion criteria: Patients between 30 and 70 years old with opium addiction who are candidate for elective coronary bypass on-pump surgery.
The major exclusion criteria: History of previous anesthesia for cardiac surgery; ASA Physical Status Classification System more than 4, History of alcohol consumption; History of addiction to opium; History of long-term use of psychotropic drugs or tranquilizers.
Age
From 30 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
patients are divided randomly by encoding. Researchers and patients are unaware
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Postal code
Approval date
2013-09-09, 1392/06/18
Ethics committee reference number
920405
Health conditions studied
1
Description of health condition studied
investigation of effect of anesthesia drug consumption
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
The total amount of medication (Fentanyl and Propofol) to achieve the desired depth of anesthesia
Timepoint
During surgery and at the time of extubation after surgery
Method of measurement
Clinical check list by researchers and the bispectral Index monitor
2
Description
Awareness during anesthesia
Timepoint
24 hour after extubation
Method of measurement
Questionnaire with open questions
3
Description
Depth of anesthesia (40-60)
Timepoint
During surgery and at the time of extubation after surgery
Method of measurement
The bispectral Index monitor
4
Description
The total amount of extra medication (Fentanyl and Propofol) to achieve the desired depth of anesthesia
Timepoint
During surgery and at the time of extubation after surgery
Method of measurement
Clinical check list by researchers
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hypothermic condition, after aortic cannulation by cardiopulmonary bypass pump, body is slowly cooled till (28-32 ° C)
Category
Diagnosis
2
Description
Control group: normothermic condition, At the end of surgery patient's body temperature is warmed till (36 Centigrade) by blanket under patient
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Shima Sheybani
Street address
Anesthesia group, Ghaem Hospital, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
sheybanish@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
sheybanish@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Ali Rahdari
Position
Resident
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Mashhad
City
Mashhad
Postal code
Phone
00985118671352
Fax
Email
sheybanish@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)