Shivering is one of the most common intra and postoperative problems with a 20%-60% reported incidence. In addition to patient's discomfort, intra and postoperative hypothermia and shivering interfere with patent's monitoring and can increase oxygen consumption and CO2 production. Recently α–2 agonists like dexmedotomidine due to central hypothalamic thermoregulation have been shown to be effective in the prevention of intra and postoperative shivering. The aim of this study is to evaluate the effect of dexmedotomidine in prevention of shivering in patients undergoing to cesarean section with spinal anesthesia with suggestion that prophylactic administration of this agent can prevent inta and postoperative shivering or reduce its severity.
After obtaining written informed consent for entering to study, 70 pregnant patients scheduled for cesarean section will enrolled in two groups of 35 and receive spinal anesthesia. Case or dexmedotomidine group will be administered 1 μg/kg dexmedotomidine in 20 ml normal saline immediately after delivery and cord clamping and the control group will receive normal saline as placebo in the same volume. The incidence and severity of inta and postoperative shivering will be checked and recorded according to Crossley and Mahjon scores. Shivering scores equal or higher than 3 will be treated with 0.5 mg/kg IV Meperidine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070210765N9
Registration date:2016-12-10, 1395/09/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-10, 1395/09/20
Registrant information
Name
Sousan Rasooli
Name of organization / entity
Alzahra hospital/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
rasoolis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center, Tabriz University of Medical Sciences
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prevention of Shivering During and Post Cesarean Section with Spinal Anesthesia
Public title
The Effect of Intravenous Dexmedetomidine for Prevention of Shivering During and Post Cesarean Section with Spinal Anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: parturients aged 18-42 years old; patients with ASA class I & II; patients signed informed consent.
Exclusion criteria: parturients with ASA class III or high; contraindication for spinal anesthesia; diabetics; preterm labor; hypertension; preeclampsia and eclampsia; allergy; drug or alcohol abuse; cardiovascular disease; respiratory disease; renal and hepatic disease; hypo or hyperthermic disease.
Age
From 18 years old to 42 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Scienses, Golgasht Ave.
City
Tabriz
Postal code
Approval date
2016-07-04, 1395/04/14
Ethics committee reference number
IR.TBZMED.REC.1395.319
Health conditions studied
1
Description of health condition studied
Hypothermia following anaesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia(Hypothermia following anaesthesia)
Primary outcomes
1
Description
severity of shivering
Timepoint
Intra and postoperative
Method of measurement
Crossley and Mahjon scale
Secondary outcomes
1
Description
Mepridine requairments
Timepoint
Intra and postoperative
Method of measurement
Crossley and Mahjon scale
Intervention groups
1
Description
Intervention or dexmedotomidine group will be administered 1 μg/kg dexmedotomidine in 20 ml normal saline immediately after delivery and cord clamping.
Category
Treatment - Drugs
2
Description
Control group will receive normal saline as placebo in the same volume.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Sousan Rasouli
Street address
Alzahra Hospital, South Artesh Ave, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center, Tabriz University of Medical Sciences
Full name of responsible person
ٍElahi Madarek
Street address
Vice chancellor for reaserch, No 2, Central bulding of Tabriz University of Medical Scienses, Golgasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center, Tabriz 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
Reaserch center, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
rasooli_s@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reaserch Center, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
rasooli_s@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reaserch center, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave.
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
Rasooli_s@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)