The aim of this study is to compare the effect of propofol with midazolam on headache after spinal puncture . Inclusion criteria:Age 20 to 80 years old ؛ sign the written consent. Exclusion Criteria: the patients aren’t included in the first and second class (based on the American Society of Anesthesia classification); coagulopathy disorders; hemodynamic disorders.This study is a double blind clinical trial.80 patients whom refer to the operating room of 15 khordadad hospital of Gonabad for elective surgery in the sitting position are injected with the 25 quinke spinal needle in the space between L4 and L5 through marcaine drug. In this study, half of the patients take 30 mic/kg/min propofol with /02 mg/kg midazolamand for sedation and The patients were examined for headache (none, mild, moderate, or severe) each 6 h to 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120712312N3
Registration date:2016-01-21, 1394/11/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-21, 1394/11/01
Registrant information
Name
Mohammadtaghi Khodadadi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 1114
Email address
dr_khodadadi_m@yahoo.com
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology Gonabad University of Medical Sciences
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of propofol and midazolam sedation dose on patients headache after spinal anesthesia
Public title
The Effect of propofol and midazolam on patients headache after spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients who have been admitted as an elective surgery between 20 and 80years old؛ sign the written consent.
Exclusion Criteria: the patients aren’t included in the first and second class (based on the American Society of Anesthesia classification); not to sign the written consent; to have an underlying disease; to report any acute or chronic headache before spinal puncture; to take pain medication in the last two days; coagulopathy disorders; hemodynamic disorders; abscesses and local infection of the soft tissue or skin in the injection site; severe restlessness; brain lesion; severe mental disorders and addictions.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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 comity of vice research of Gonabad University of Medical Sciences
Street address
Pardice ،Gonabad University of Medical Sciences
City
Gonabad،
Postal code
9691793718
Approval date
2015-12-23, 1394/10/02
Ethics committee reference number
IR.GMU.REC.1394.62
Health conditions studied
1
Description of health condition studied
post spinal headache
ICD-10 code
G97.1
ICD-10 code description
Other reaction to spinal and lumbar puncture
Primary outcomes
1
Description
Headache
Timepoint
q 6 hr for 24 houre
Method of measurement
vas and check list
Secondary outcomes
empty
Intervention groups
1
Description
Prescription of intravenous propofol 30 ug/kg/min for sedation post spinal
Category
Treatment - Drugs
2
Description
Prescription of intravenous midazolam /02mg/kg for sedation post spinal
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
15 khordadad bidokht haspital
Full name of responsible person
Dr Mohammad Taghi Khodadadi
Street address
Gonabad Medical University of Sciences
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and technolgy of Gonabad University of Medical Sciences
Full name of responsible person
Dr Alireza Mohammadzade
Street address
Gonabad
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and technolgy of Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Dr Mohammad Taghi Khodadadi
Position
Anesthesiologist
Other areas of specialty/work
Street address
15 Khordad bidokht haspital ،Gonabad
City
Gonabad
Postal code
9691793718
Phone
+98 51 5723 1114
Fax
+98 57231114
Email
dr_khodadadi_m@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Mohammad Taghi Khodadadi
Position
Anesthesiologist
Other areas of specialty/work
Street address
bidokht haspital،Gonabad
City
Gonabad
Postal code
9691793718
Phone
+98 51 5723 1114
Fax
+98 51 5723 1114
Email
dr_khodadadi_m@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical sciences
Full name of responsible person
Dr Mohammad Taghi Khodadadi
Position
Anesthesiologist
Other areas of specialty/work
Street address
15 Khordada bidokht haspital،Gonabad
City
Gonabad
Postal code
9691793718
Phone
+98 51 5723 1114
Fax
+98 57231114
Email
dr_khodadadi_m@yahoo.com
Web page address
mahdikh55@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)