Study Objective: To comparison of different classes of anti-shivering drug such as ketamine , Hydrocotisone, tramadol, meperidine, and magnesium sulfate for prevention of shivering after general anesthesia.
Study design: randomized, double-blind, placebo-controlled trial, phase II ,single-center,
the inclusion criteria: All patients undergoing elective laparotomy and general anesthesia
the exclusion criteria: have history of disease that cause or affect or impair shivering and any condition that requires treatment during the study.
Sample size: 40 patients for each group.
intervention: drug injection.
Time of intervention: during surgery .
primary outcome: Effects of drugs on shivering control
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209187686N2
Registration date:2012-11-13, 1391/08/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-13, 1391/08/23
Registrant information
Name
Hesameddin Modir
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 9793
Email address
dr.hemodir@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences,Vice chancellor for research
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of different classes of drugs for prevention of shivering after general anesthesia
Public title
Comparative efficacy of different classes of drugs for prevention of shivering after general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients undergoing elective laparotomy under general anesthesia; age between 20 to 45 years and ASA grade I or II.
Exclusion criteria: history of heart disease; history of lung disease;history of thyroid disease; history of neuromuscular disorders; liver or kidney dysfunction;
alcohol abuse; drug abuser; Shivering during surgery and any complications during surgery that may require medical intervention.
Age
From 20 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
240
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
Ethical Committee of Arak University of Medical Sciences
Street address
Alamolhoda Ave, Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
91-126-1
Health conditions studied
1
Description of health condition studied
Abnormal involuntary movements
ICD-10 code
R25
ICD-10 code description
Abnormal involuntary movements Excl: specific movement disorders , stereotyped movement disorders, tic disorders
Primary outcomes
1
Description
Post Anesthetic shivering
Timepoint
0, 10 and 20 minutes after entry to recovery room
Method of measurement
Quality Grading
2
Description
Body temperator
Timepoint
0, 10 and 20 minutes after entry to recovery room
Method of measurement
Digital Termometer
Secondary outcomes
1
Description
Saturation of Arterial O2
Timepoint
Before induction of Anaesthesia
Method of measurement
Palsoximetry
2
Description
Heart rate
Timepoint
before induction of Anaesthesia
Method of measurement
cardiac Monitoring
Intervention groups
1
Description
The first group consisted of patients who receive intravenous 2 mg/ kg Hydrocortisone ten minutes before the end of surgery
Category
Treatment - Drugs
2
Description
The second group consisted of patients who received intravenous 0.5 mg/ kg ketamin 20 minutes before the end of surgery
Category
Treatment - Drugs
3
Description
The third group consisted of patients who received slow IV infusion 2 mg/ kg tramadol 30 minutes before the end of surgery
Category
Treatment - Drugs
4
Description
The fourth group consisted of patients received bolus intravenous 80 mg/ kg magnesium sulfate
Category
Treatment - Drugs
5
Description
The fifth group includes patients that received intravenous injection of 0.4 mg/ kg meperidine before the end of surgery
Category
Treatment - Drugs
6
Description
The sixth group consisted of patients that revived intravenous 10 to 15 ml/ per kg of normal saline isothermal to the operating room during surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr hospital
Full name of responsible person
Dr Hesamaldin Modir
Street address
Vali-Asr hospital, Pirouzi Ave
City
Arak
2
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Hesamaldin Modir
Street address
Amiralmomenin Hospital, Basij Square
City
Arak
3
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr Hesamaldin Modir
Street address
Amirkabir Hospital, Parastar Square
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences,Vice chancellor for research
Full name of responsible person
Dr Saeed Changizi Ashtiani
Street address
Arak University Of Medical Science, Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences,Vice chancellor for research
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
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamaldin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Science, Alamolhoda Ave
City
Arak
Postal code
Phone
+98 86 1313 9793
Fax
Email
dr.hemodir@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamaldin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Science, Alamolhoda Ave
City
Arak
Postal code
Phone
+98 86 1313 9793
Fax
Email
dr.hemodir@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamaldin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Science, Alamolhoda Ave
City
Arak
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)