1. Home
  2. Approved trials
  3. » فارسی

The effect of intravenous adminastration of Aminophylline on prevention of post spinal Anesthesia Headache in patients undergoing elective cesarean Section

Protocol summary

Summary
Background & Purpose: In this study the effect of intravenous administration of Aminophylline on prevention of post spinal headache was evaluated. Design of experiments: double blind clinical trial Methods: Patients randomly divided into 2 groups. Inclusion criteria:140 patients candidate spinal anesthesia at the age of 18-35 and set in class I & II of Anesthesia Society of America (ASA) was selected. Exclusion criteria:Patients with history of cardiovascular disease, cerebral, Hypertension, Diabet mellitus, Preeclampsia, Seizure, Migrain, History of Post spinal anesthesia headache, Unwilling to spinal anesthesia to experience spinal anesthesia, coagulopathy,Psychiatry. Intervention: patients were randomly allocated into 2 groups recieving either 100 cc of normal salin or 1 mg/kg aminophylline dissolved in 100 cc of normal salin after delivery & cord clamping. 4,8,24,48,72 hours after operation the occurance of headache was evaluated according to VAS score.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201411294923N6
Registration date: 2015-01-08, 1393/10/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-08, 1393/10/18
Registrant information
Name
Bahman Hasannasab
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
bahmanh2002@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research Babol University Of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous adminastration of Aminophylline on prevention of post spinal Anesthesia Headache in patients undergoing elective cesarean Section
Public title
The effect of intravenous adminastration of Aminophylline on prevention of post spinal Anesthesia Headache in patients undergoing elective cesarean Section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients candidate for spinal anesthesia set in class I & II of Anesthesia Society of America (ASA) was selected, Exclusion criteria: Patients with history of cardiovascular desease, cerebral, Hypertention,Diabet mellitus, Preeclampsia, Seizure, Migrain, History of Post spinal anesthesia headache, Unwilling to spinal anesthesia to experience spinal anesthesia, coagulopathy,Psychiatry.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2014-07-08, 1393/04/17
Ethics committee reference number
4323/30/ژ/پ

Health conditions studied

1

Description of health condition studied
Post spinal anesthesia headache
ICD-10 code
G97.1
ICD-10 code description
Other reaction to spinal and lumbar puncture

Primary outcomes

1

Description
Post spinal anesthesia headache
Timepoint
4,8,24,48,72 hours after operation
Method of measurement
Score pain

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before and after spinal anesthesia and delivery and cord clamping and after drug injectionand then every 5 minutes until the end of operation
Method of measurement
Non- invasive manometer

2

Description
Heart rate
Timepoint
Before and after spinal anesthesia and delivery and cord clamping and after drug injectionand then every 5 minutes until the end of operation
Method of measurement
Heat rate monitoring

Intervention groups

1

Description
Prevention group: Intravenous injection of aminophylline 1 mg/kg in 100 cc normal salin
Category
Prevention

2

Description
Control group: injection of 100 cc normal salin
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ruhani Hospital
Full name of responsible person
Dr bahman hasannasab
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz 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
Ali Akbar 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 Bahman Hasannasab
Position
Assistant 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 3223 8296
Fax
Email
bahmanh2002@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 manijeh yazdanmehr
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
babol
Postal code
Phone
+98 11 3223 8296
Fax
Email
bahmanh2002@yahoo.comans_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 bahman hasannasab
Position
Assistant 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 3223 8296
Fax
Email
bahmanh2002@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...