Protocol summary

Summary
The aim of this study is evaluating the effect of prophylactic single dose of sublingual desmopressin on post dural puncture headache after spinal anesthesia. After taking letter of satisfaction from patients for desmopressin use and educating about VAS to evaluate headache severity, Patients will be divided into 2 groups: 1) study and 2) placebo. In study group patients will be receive one 60 micro gram Minirin melt tablet (sublingual) 10 minutes before spinal anesthesia. Inclusion criteria: 1) all 18-60 years old patients which are candidate for elective surgery by spinal anesthesia. 2)ASA I-II. Exclusion criteria: 1) history of migrain headache. 2) history of backache. 3) history of heart failure and renal failure. 4) history of hypertension. 5) history of spinal anesthesia or lumbar puncture in the recent month. 6) history of puncture more than two times. 7) history of high ICP. 8) electrolyte disturbance. 9) psychopathic condition. 10) other contraindications for spinal anesthesia such as local infection and coagulopathy. The questioner person who is a medicine student isn't aware of Minirin prescription. In placebo group patients will be received a piece of starch in the size of Minirin tablet. At the end ,per 24 hours during one week existence of headache and it's severity will be measured by VAS,if suffering headache, patients would receive therapy. The main variable in this study (headache severity) is a qualitative dependent variable. For parametric variables with normal distribution curve "independent T test" or "unpaired T test" and for parametric data with abnormal distribution "mann whithney" and for qualitative variables K square test2 " and also about frequent measurements "repeated measures dependent variable test" will be used. Data will be studied by SPSS15 statistic software. P<0.05 will be sensitive statistically.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031416956N5
Registration date: 2015-06-16, 1394/03/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-16, 1394/03/26
Registrant information
Name
Hassan Mohammadipour Anvari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
dr.anvari22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic single dose of sublingual desmopressin on post dural puncture headache after spinal anesthesia.
Public title
Effect of desmopressin on post dural puncture headache after spinal anesthesia. ‌
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1) all 18-60 years old patients wich are candidate for elective surgery by spinal anesthesia. 2)ASA I-II. Exclusion criteria: 1)history of migrain headache. 2)history of backache. 3)history of heart failure and renal failure. 4)history of hypertension. 5)history of spinal anesthesia or lumbar puncture in the recent month. 6)history of puncture more than two times. 7)history of high ICP. 8)electrolyte disturbance. 9)psychopathic condition. 10)other contraindications for spinal anesthesia such as local infection and coagulopathy.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Tabriz medicine university
Street address
Tabriz.university sq
City
Tabriz
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
9/4_4/2

Health conditions studied

1

Description of health condition studied
The Post dural puncture headache after spinal anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
Headache severity
Timepoint
Per 24 hours during one week
Method of measurement
By VAS

Secondary outcomes

1

Description
vomiting & nausea
Timepoint
Daily
Method of measurement
questionnaire

2

Description
oedema
Timepoint
Daily
Method of measurement
questionnaire

3

Description
hypertention
Timepoint
Daily
Method of measurement
questionnaire

Intervention groups

1

Description
Study group: Minirin tablet(60 micro gram)will give10 minute before spinal anesthesia
Category
Prevention

2

Description
Control group:a piece of starch will give before spinal anesthesia
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospitol
Full name of responsible person
Hassan Mohammadipour Anvari
Street address
Daneshgah sq
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sceinces
Full name of responsible person
Dr Hassan soleimanpour
Street address
Tabriz university of Medical Sceinces
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sceinces
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
Tabriz University of Medical Sceinces
Full name of responsible person
Hassan Mohammadipoor Anvari
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
dr.anvari22@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sceices
Full name of responsible person
Hassan Mohammadipoor Anvari
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Reza hospitol
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
dr.anvari22@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Mohammadipour Anvari
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Reza hospitol
City
Tabriz
Postal code
Phone
+98 918 811 2210
Fax
Email
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
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