The aim of this study is assessing the effect of added fentanyl to lidocain in the amount of shivering after abdominal hysterectomy in women. 70 women candidated for abdominal hysterectomy without histoy of allergy, cancer, obesity (body mass indexy 30kg/m2), contraindication to a spinal puncture will include in study and randomly divided into 2 groups.Group 1 will undergo spinal anesthesia using 75mg lidocain 5% and additional 30μg of fentanyl intrathecally. Group 2 will undergo spinal anesthesia using 75mg lidocain 5% and normal salin 0.6cc . The amount of of shivering three hours after spinal anesthesia will b measured according to crossly&mahajon Scale.Data will be assessed by chi-square test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015022416162N2
Registration date:2015-04-20, 1394/01/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-20, 1394/01/31
Registrant information
Name
Masoomeh Nataj Majd
Name of organization / entity
Arash Womens Hospital, Tehran Medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
hosparash@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of intrathecal fentanyl added to lidocain on shivering in women after abdominal hysterectomy
Public title
Effect of fentanyl and lidocain drugs in shivering after surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Incusion criteria:Patients condidate for abdominal hysterectomy
Exclusion criteria: Patients with allergy, cancer, obesity (body mass indexy 30kg/m2), contraindication to a spinal puncture, patients on narcotics or sedatives
Age
From 35 years old to 55 years old
Gender
Female
Phase
N/A
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
Ethic committee of Zahedan Uviversity of Medical Sciences
Street address
Zahedan Uviversity of Medical Sciences, Khlije Fars boulevard, Zahedan
City
Zahedan
Postal code
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
124524-4 -93
Health conditions studied
1
Description of health condition studied
shivering after surgery
ICD-10 code
R25.1
ICD-10 code description
Tremor, unspecified
Primary outcomes
1
Description
shivering
Timepoint
3 hours after surgery
Method of measurement
observational
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group will undergo spinal anesthesia using 75mg lidocain 5% and additional 30μg of fentanyl intrathecally.
Category
Treatment - Drugs
2
Description
Control Group will undergo spinal anesthesia using 75mg lidocain 5% and normal salin 0.6cc .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abitleb Hospital
Full name of responsible person
Dr. Masoomeh Nataj Majd
Street address
Zahedan University of Medical Sciences, Dr. Hesabi square
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hooshang Rafighdoost
Street address
Zahedan University of Medical Sciences, Khalij Fars boulevard
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Zahedan 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
Zahedan University Of Medical Sciences
Full name of responsible person
Dr.Masoomeh Nataj Majd
Position
Anesthesiologist
Other areas of specialty/work
Street address
Zahedan Uviversity of Medical Sciences, Khlije Fars boulevard, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3339 5796
Fax
Email
mnataj@farabi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University Of Medical Sciences
Full name of responsible person
Dr. Masoomeh Nataj Majd
Position
Anesthesiologist
Other areas of specialty/work
Street address
Zahedan Uviversity of Medical Sciences, Khlije Fars boulevard, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3339 5796
Fax
Email
mnataj@farabi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Masoomeh Nataj Majd
Position
Anesthesiologist
Other areas of specialty/work
Street address
Zahedan Uviversity of Medical Sciences, Khlije Fars boulevard, Zahedan
City
Zahedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)