Comparison of frequency and severity of intraoperative hypothermia between general anesthesia and spinal anesthesia in patients with lower extremity procedures
This study aimed to compare the incidence and severity of hypothermia for general anesthesia and spinal anesthesia in the lower extremities is a randomized clinical trial in 60 patients undergoing lower extremity that Imam Reza (AS) visited. Patients are randomly divided in two equal groups of 30 each. Patients with ASA I, II are included and in condition that the ASA> II; addiction; blood coagulation disorders and infections patients are excluded. The first group received spinal anesthesia space L3-L4 or L4 - L5 injection of Marcaine solution (0.5%) 12-15 mg plus fentanyl 25μ. If more than 30mmHg hypotension occurs, 5-10 mg ephedrine is injected. The second group underwent induction of anesthesia with propofol (2ml/kg) and Atracurium (0.5 ml/kg) are placed. After intubation, anesthesia with propofol (100μ/kg/min) oxygen and 50% nitrous oxide and fentanyl 50μ every half hour is used as a preservative. Symptoms hemodynamic (heart rate, systolic and diastolic), oxygen saturation, temperature, forehead and tympanic beginning of anesthesia and then every 30 minutes until the end of surgery and transferred to the recovery room monitors are. Patients under general anesthesia after surgery, patients undergoing spinal anesthesia during surgery and recovery and transfer are assessed for shivering.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042917480N1
Registration date:2014-05-21, 1393/02/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-21, 1393/02/31
Registrant information
Name
Mostafa Delshad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1606 6269
Email address
delshadm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of frequency and severity of intraoperative hypothermia between general anesthesia and spinal anesthesia in patients with lower extremity procedures
Public title
Evaluation of heat loss during anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing lower extremity; new ASA I, II; consent to participate in the study.
Exclusion: ASA> II; a lack of consent to spinal anesthesia; any prohibitive (in terms of anesthesia and surgery) for spinal anesthesia, drugs, blood coagulation disorders, infections, spinal area; patients who have contraindications to general anesthesia.
Age
From 1 year old to 13 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreyshi Building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
922148
Health conditions studied
1
Description of health condition studied
Hypothermia during and after surgery
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Hypothermia
Timepoint
Ambient temperature, the top of the forehead and tympanic membrane anesthesia and then every 30 minutes until the end of the surgery and the recovery
Method of measurement
digital thermometer (beurer) Model FT55
Secondary outcomes
1
Description
Duration of surgery
Timepoint
Duration of anesthesia and patient recovery
Method of measurement
Minute
Intervention groups
1
Description
The first group received spinal anesthesia space L3-L4 or L4 - L5 injection of Marcaine solution ( 0.5%) 12-15 mg plus fentanyl 25μ are.More than 30mmHg hypotension occurs, the patient is injected mg10 - 5 ephedrine are treated.
Category
Treatment - Other
2
Description
The second group underwent induction of anesthesia with propofol (2ml/kg) and Atracurium (0.5 ml/kg) are placed. After intubation, anesthesia with propofol (100μ/kg/min) oxygen and 50% nitrous oxide and fentanyl 50μ every half hour is used as a preservative.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac Anesthesia Research Center
Full name of responsible person
Dr. Mehryar Taghavi Gilani
Street address
Cardiac Anesthesia Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Ghoreyshi Building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Dr. Mehryar Taghavi Gilani
Position
Associate Professor
Other areas of specialty/work
Street address
Cardiac Anesthesia Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
taghavim@mums.ac.ir
Web page address
http://www.mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mehryar Taghavi Gilani
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Cardiac Anesthesia Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
taghavim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mostafa Delshad
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Cardiac Anesthesia Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1606 6269
Fax
Email
delshadm1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)