5-7ml/kg Voluven was administered in 100 patients of the trial group who where candidates of cesarean section with spinal anesthesia. In order to evaluate the effect of voluven. Administration in incidence rate of post spinal headache and evaluated PSH daily until one week post spinal headache. Patients contraindicated of LP; psychotic or patients with space occupying lesion; addicts; corticosteroid and NSAID users.In control group patients ,5-7ml/kg ringer serum was administered and incidence rate of headache was evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308243305N5
Registration date:2014-12-20, 1393/09/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-20, 1393/09/29
Registrant information
Name
Ebrahim Alijanpour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1228 0013
Email address
dralijanpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University Of Medical Sciences
Expected recruitment start date
2013-07-11, 1392/04/20
Expected recruitment end date
2014-09-11, 1393/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of voluven on post spinal headache in patients with cesarean section
Public title
Effect of voluven on post spinal headache in patients with cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: All of patients who are candidates for Cesarean section with Spinal anesthesia.
Exclusion Criteria: Patients contraindicated of LP; psychotic or patients with space occupying lesion; addicts; corticosteroid and NSAID users.
Age
No age limit
Gender
Both
Phase
2
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2013-07-02, 1392/04/11
Ethics committee reference number
2726/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Post spinal headache
ICD-10 code
G44.8
ICD-10 code description
Other specified headache syndromes
Primary outcomes
1
Description
Headache
Timepoint
daily until one week post spinal headache
Method of measurement
Question & answer
Secondary outcomes
1
Description
Blood pressure
Timepoint
During spinal anesthesia
Method of measurement
BP Cuff
2
Description
Heart rate
Timepoint
During spinal anesthesia
Method of measurement
ECG
3
Description
Nausea & Vomiting
Timepoint
During spinal anesthesia
Method of measurement
Question & answer
4
Description
Arterial oxygen saturation
Timepoint
During spinal anesthesia
Method of measurement
pulse oximeter
Intervention groups
1
Description
Intervention: administration of 5-7ml/kg voluven after spinal anesthesia
Category
Prevention
2
Description
Control:administration of 5-7ml/kg ringer serum after spinal anesthesia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Ebrahim ALijanpour
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
2
Recruitment center
Name of recruitment center
shahid Beheshti Hospital
Full name of responsible person
Dr Ebrahim Alijanpour
Street address
shahid ghasemi Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Aliakbar Moghadamnia
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol 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
Babol University Of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
dralijanpour@yahoo.com, ans_dep@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
dralijanpour@yahoo.com, ans_dep@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)