The aim of this study is to investigate the effect of Granisetron to preventing of shivering during and after of spinal anesthesia for Caesarean section . This study is a double blind clinical trial on 60 female patients undergoing non-emergency elective cesarean section. Patient temperature,operating room temperature and tympani measured and recorded during surgery. Standard monitoring for all patients, including MAP, DBP, SBP, HR and ECG continuously since before anesthesia until the transfer is done. Spinal anesthesia induces with Quincke 25-gauge spinal anesthesia needle at L3-L4 space using 5/12 mg of Marcaine 5/0% for all patients. Immediately after spinal ansthesia granisetron is administered to the patients in the study group and the placebo to control group. If the pressure (SBP) below 100mm Hg ephedrine 5mg IV is administrate.In case of bradycardia (PR <50/min) 0/5mg IV atropine is injected to the patient. Granisetron common side effects (headache, drowsiness, diarrhea) is recorded. Patient temperature results is recorded at specified time. inclusion criteria: age 18_40 years old; undergoing spinal anesthesia for cesarean delivery. exclusion criteria: hyperthyroidism; cardiopulmonary diseases; history of drug abuse.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008214583N2
Registration date:2013-08-31, 1392/06/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-31, 1392/06/09
Registrant information
Name
Hossein Moshtaghion
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1525 0207
Email address
moshtaghion@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of granisetron on preventing of shivering during and after spinal anesthesia for cesarean delivery
Public title
effect of granisetron on preventing of shivering during and after spinal anesthesia for cesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age 18_40 years old; undergoing spinal anesthesia for cesarean delivery.
exclusion criteria: hyperthyroidism; cardiopulmonary diseases; history of drug abuse.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine, Shahid Sadoughi University of Medical Sciences and Health
Street address
yazd international pardis
City
yazd
Postal code
Approval date
2013-06-22, 1392/04/01
Ethics committee reference number
9101
Health conditions studied
1
Description of health condition studied
shivering after spinal anesthesia
ICD-10 code
E35.8
ICD-10 code description
Disorders of other endocrine glands in diseases classified elsewhere
Primary outcomes
1
Description
shivering during and after spinal anesthesia
Timepoint
each 10 min during surgery until recovery
Method of measurement
by thermometer
Secondary outcomes
1
Description
core body temperature
Timepoint
each 10 min during surgery until recovery
Method of measurement
by thermometer
Intervention groups
1
Description
placebo
Category
Treatment - Drugs
2
Description
Granisetron
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
operating room, shahid sadoughi hospital
Full name of responsible person
dr moshtaghion
Street address
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahid sadoughi medical science university
Full name of responsible person
dr hassan mozaffari
Street address
bahonar square
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahid sadoughi medical science 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 Sadoughi University of Medical Sciences
Full name of responsible person
dr s. hossein moshtaghion
Position
associate Professor of anesthesiology
Other areas of specialty/work
Street address
shahid sadoughi hospital
City
yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
moshtaghion@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
dr s. hossein moshtaghion
Position
associate Professor of anesthesiology
Other areas of specialty/work
Street address
shahid sadoughi hospital
City
yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
moshtaghion@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
dr s hossein moshtaghion
Position
associate Professor of anesthesiology
Other areas of specialty/work
Street address
shahid sadoughi hospital
City
yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
moshtaghion@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)