Protocol summary

Study aim
The effect of intravenous aminophylline on post- spinal anesthesia headache in women under cesarean section
Design
Clinical practice with control and intervention group, with parallel groups, simple randomized triple blind
Settings and conduct
In this clinical trial study in Ninth Diabetes Hospital in 1397, each patient was enrolled by an anesthetist after an appointment and then examined for exit criteria. Then, the researcher will prescribe one of the two drugs based on the previously prepared randomized form and the nurse is not known to have any type of drug. For patients who are eligible, the pain questionnaire is filled up before and after 24 hours.
Participants/Inclusion and exclusion criteria
Entry Requirement: Satisfaction to participate in the study Subjected to cesarean section with spinal anesthesia No history of sensitivity to aminophylline or other xanthine derivatives with accurate history from them. Age 45-18 years Lack of history of migraine headaches, coagulation disorders, gestational toxicity, diabetes, seizure, smoking and narcotics, and cardiovascular diseases Conditions for not admitting to study: Performing a retinal anxiety Unwillingness to cooperate in the study General anesthesia Use of xanthine derivatives during the study
Intervention groups
Patients in both intervention and control groups randomly received aminophylline and normal serum saline (0.09%) and normal serum saline (0.09%).
Main outcome variables
Headache

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180607040003N1
Registration date: 2018-09-03, 1397/06/12
Registration timing: retrospective

Last update: 2018-09-03, 1397/06/12
Update count: 0
Registration date
2018-09-03, 1397/06/12
Registrant information
Name
Hosein Bayesteh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5224 3329
Email address
hosein_bayesteh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-04-21, 1397/02/01
Trial completion date
empty
Scientific title
Effect of intravenous aminophylline on post- spinal anesthesia headache in women under cesarean section
Public title
Effect of intravenous aminophylline on post- spinal anesthesia headache in women under cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study Subjected to cesarean section with spinal anesthesia No history of sensitivity to aminophylline or other xanthine derivatives with accurate history from them. Age 45-18 years Lack of history of migraine headaches, coagulation disorders, gestational toxicity, diabetes, seizure, smoking and narcotics, and cardiovascular diseases
Exclusion criteria:
Performing a retinal anxiety Unwillingness to cooperate in the study General anesthesia Use of xanthine derivatives during the study
Age
From 18 years old to 45 years old
Gender
Female
Phase
1
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Available sampling from all women candidates for cesarean section with spinal anesthesia referred to Razi Torbat Heydarieh Hospital and Allameh Bhlol Gonabadi Hospital in Gonabad city, after being eligible for inclusion criteria by random allocation method using blocks Reversal, so that the number 1 as an intervention group (the group receiving aminophylline 3 mg based on the ideal body weight and 500 ml normal saline 0.9% venous) and the number 2 as the control group (receiving group 500 C C is considered to be 0.9% venous saline), and 4-block blocks (eg 2121) in the theme
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients in the intervention group, after obtaining informed consent and entering the study, are not aware of which amniotic fluid injectable serum are available. Also, the clinical caregiver of the intervention group is unaware. Only the researcher has prepared the serum and the name of the patient in the intervention group and It will provide control to the clinical care provider for infusion, as well as assessing the outcome of the pain, the clinician will do without the knowledge of the intervention and control group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Asian Roadside Border
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2017-12-17, 1396/09/26
Ethics committee reference number
IR.GMU. REC.1396.62

Health conditions studied

1

Description of health condition studied
Headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes

Primary outcomes

1

Description
Headache
Timepoint
24h
Method of measurement
observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Headache before giving aminophylline in the aminofilin dose group. In this study, 3 cc per kg body weight of the drug are given at the diagnosis of the headache, and after an hour the patient is examined by the doctor and the healing It is recorded.
Category
Treatment - Drugs

2

Description
Control group: For patients in the control group, only 500 cc normal saline 0.9% intravenous infusion is infused over 2 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Women's Hospital, 9day
Full name of responsible person
hoseyn bayeste
Street address
Razi Ave,Ferdowsi Blv
City
Torbat heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6013
Email
m.eshaghzadeh93@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
hoseyn bayesteh
Street address
Asian Roadside Border
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5222 6013
Email
m.eshaghzadeh93@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
hoseyn bayeste
Position
Master student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Asian Roadside Border
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5222 6013
Email
m.eshaghzadeh93@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
hoseyn bayesteh
Position
Master student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Asian Roadside Border
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
m.eshaghzadeh93@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
hoseyn bayesteh
Position
Master student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Asian Roadside Border
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
m.eshaghzadeh93|@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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