A comparison of prophylactic use of meperidine, meperidine plus dexamethasone, and ketamin plus midazolam for preventing of shivering during spinal anesthesia:A Randomized, Double blind, Placebo-Controlled study.
In this prospective, double blind, placebo controlled study 200 ASA I and II patients undergoing orthopedic or urologic surgery under spinal anesthesia are included.Subarachnoid anesthesia is performed by using 15 mg of 0.5%hyperbaric bupivacaine.Patients are randomly allocated to receive saline(placebo,Group C), meperidine 0.4 mg/kg(Group M), ketamine 0.25 mg/kg plus midazolam 37.5 µg/kg(Group KM), and meperidine0.2 mg/kg plus dexamethasone 0.1 mg/kg(Group MD).All drugs are given as an intravenous (i.v) bolus immediately after intrathecal injection.During surgery and stay in the recovery room shivering score, blood pressure and some other adverse effects are recorded at 5 minutes interval.Axillary and tympanic temperature are recorded at 15 min intervals during the perioperative period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120220185N1
Registration date:2015-01-10, 1393/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-10, 1393/10/20
Registrant information
Name
ALI SOLHPOUR
Name of organization / entity
SHAHID BEHESHTI MEDICAL UNIVERSITY
Country
Iran (Islamic Republic of)
Phone
+98 21 2254 3731
Email address
solhpourali@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-01-09, 1393/10/19
Expected recruitment end date
2015-02-09, 1393/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of prophylactic use of meperidine, meperidine plus dexamethasone, and ketamin plus midazolam for preventing of shivering during spinal anesthesia:A Randomized, Double blind, Placebo-Controlled study.
Public title
The effect of combination of dexamethasone and meperidine intravenously in prevention of post-spinal anesthesia.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:patients with elective orthopedic or urologic surgery aged between 20 and 60 years old.
Exclusion criteria: Patients with cardiopulmonary disease; hypothyroidism or hperthyroidism; patients with psychologic disorders, a need for transfusion during surgery; an initial body temperature more than 38 or less than 36◦ C; a known history of alcohol or substance abuse; or receiving vasodilators; or medications likely to alter thermoregulation; patients with spinal anesthesia failure.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti Medical University
Street address
Chamran highway, Yaman street, Arabi street, Shahid Beheshti Medical University
City
Tehran
Postal code
Approval date
2013-12-01, 1392/09/10
Ethics committee reference number
SBMU.rec.1392.485
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Shivering score
Timepoint
Thirty minutes after spinal anesthesia
Method of measurement
Observation based on Tsai scale
Secondary outcomes
1
Description
Surface and core temperature
Timepoint
Every 15 minutes
Method of measurement
Based on centigrade,Ear termometer for core temperature and axillary termometer for surface temperature
Intervention groups
1
Description
Meperidine 0.4 mg/kg, intravenously bolus immediately after intrathecal injection
Category
Prevention
2
Description
Ketamine 0.25 mg/kg plus midazolam 37.5 µg/kg, intravenously bolus immediately after intrathecal injection
Category
Prevention
3
Description
Meperidine 0.2 mg/kg plus dexamethasone 0.1 mg/kg, intravenously bolus immediately after intrathecal injection
Category
Prevention
4
Description
Normal saline 5 cc, intravenously immediately after intrathecal injection as placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Solhpour
Street address
Department of Anesthesiology, Labafinejad hospital, 9th Boostan, Pasdaran street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Ali Solhpour, Alireza Jafari
Street address
Chamran highway,Yaman street, Arabi street, Shahid Behesti Medical University
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Medical University
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Solhpour
Position
Medical Doctor, Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, Labafinejad hospital, 9th Boostan, Pasdaran street
City
Tehran
Postal code
Phone
+98 21 2254 3731
Fax
Email
solhpourali@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Solhpour
Position
Medical Doctor, Anesthesiologist
Other areas of specialty/work
Street address
Department of anesthesiology, Labafinejad hospital, 9th Boostan, Pasdaran street
City
Tehran
Postal code
Phone
+98 21 2254 3731
Fax
Email
solhpourali@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Solhpour
Position
Medical Doctor, Anesthesiologist
Other areas of specialty/work
Street address
Department of anesthesiology, Labafinejad hospital, 9th Boostan, Pasdaran street
City
Tehran
Postal code
Phone
+98 21 2254 3731
Fax
Email
solhpourali@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)