The aim of this study was to compare the efficacy intravenous ondansetron with ketamine plus midazolam for prevention of shivering during spinal anesthesia.American Society of Anesthesiologists (ASA) I to II patients, aged 18-65 years, who were candidate for elective orthopedic surgery with spinal anesthesia were included in this study. The other inclusion criteria were patients who had no psychological disorder, cardiopulmonary disease, hypo- or hyperthyroidism, initial body temperature > 38.0 ºC or < 36 ºC. Also, patients without known history of alcohol, substance abuse or history of receiving vasodilators or similar medications likely to alter thermoregulation were included into the present study. If there was any change in technique of anesthesia or sever bleeding which needed to blood transfusion, the patient was excluded from the study. Materials and Methods: Ninety patients, aged 18-65 years, undergoing lower extremity orthopedic surgery were included in the present study ninety Spinal anesthesia was performed in all patients with hyperbaric bupivacaine 15 mg. The patients were randomly allocated to receive normal saline (Group C), ondansetron 8 mg IV (Group O) or ketamine 0.25mg/kg IV plus midazolam 37.5 µg/kg IV (Group KM) immediately after spinal anesthesia. During surgery shivering scores were recorded at five minutes intervals. The operating room temperature was maintained at 24°C and it was standardized.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307155362N7
Registration date:2014-03-11, 1392/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-11, 1392/12/20
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Expected recruitment start date
2009-03-20, 1387/12/30
Expected recruitment end date
2010-11-21, 1389/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic use of intravenous ondansetron versus ketamine - midazolam combination for prevention of shivering during spinal anesthesia
Public title
Prophylactic use of ondansetron versus ketamine - midazolam combination for prevention of shivering during spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias:(ASA) I to II patients; aged 18-65 years; candidate for elective orthopedic surgery with spinal anesthesia
Exclusion criterias: psychological disorder; cardiopulmonary disease; hypo- or hyperthyroidism; initial body temperature > 38.0 ºC or < 36 ºC; without known history of alcohol or substance abuse ; history of receiving vasodilators or similar medications likely to alter thermoregulation; any change in technique of anesthesia ; sever bleeding which needed to blood transfusion
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:
90
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
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Street address
Alzahra Hospital Sofe street Hakim Nezami junction
City
Isfahan
Postal code
8271618566
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
338
Health conditions studied
1
Description of health condition studied
shivering after anesthesia
ICD-10 code
T88.5
ICD-10 code description
Hypothermia following anaesthesia
Primary outcomes
1
Description
shivering
Timepoint
each 5 minutes untill 24 hours after surgery
Method of measurement
observation
Secondary outcomes
1
Description
side effects of drugs such as hullosination,nausea,vomitting and hypotension
Timepoint
after injection of drugs untill 24 hoiurs
Method of measurement
observation
Intervention groups
1
Description
adding normal saline in control group
Category
Treatment - Drugs
2
Description
adding 8 mg ondansetron intravenous in O group
Category
Treatment - Drugs
3
Description
adding 0.25 mg ketamin and 37.5 mg midazolam intravenous in KM group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Mohammadreza Safavi
Street address
Kashani hospital Kashani street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi
Street address
Alzahra Hospital Sofe street Hakim Nezami junction
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesiology and Critical Care Research Center, Isfahan 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
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Alzahra Hospital Sofe street Hakim Nezami junction
City
Isfahan
Postal code
8272628566
Phone
+98 31 1668 5555
Fax
Email
safavi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Alzahra Hospital Sofe street Hakim Nezami junction
City
Isfahan
Postal code
8272628566
Phone
+98 31 1668 5555
Fax
Email
safavi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Alzahra Hospital Sofe street Hakim Nezami junction
City
Isfahan
Postal code
8272628566
Phone
+98 31 1668 5555
Fax
Email
safavi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)