Cerebrospinal fluid leak is known to be one of the side effects of spinal surgery. This usually happens when intra-dural lesions like spinal tumors andintra-spinal hemorrhage undergo surgery. In some cases, dura tear happen in trauma incidences. Due to risks of CSF leakage, prevention is essential. Acetazolamide is a carbonic-anhydraze inhibitor (a diuretic agent) which has been long used to prevent the leak, however, very few literature is available on the efficacy of this medicine. The present study will try to address this knowledge gap using a double blind randomized controlled trial comparing oral acetazolamide plus corrected body position versus corrected body position alone. Patients (n=70) undergoing spinal surgery with dura damage will be included in the study and CSF leak will be assessed as the primary outcome of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501178612N2
Registration date:2015-06-10, 1394/03/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-10, 1394/03/20
Registrant information
Name
Amir Sarayani
Name of organization / entity
Research Center for Rational Use of Drugs
Country
Iran (Islamic Republic of)
Phone
+98 21 8881 4157
Email address
a-sarayanib@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical care department-Shariati hospital
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of acetazolamide efficacy in preventing CSF leak after dural repair post spinal surgery
Public title
Effect of acetazolamide on the prevention of cerebrospinal fluid leakage after spinal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion:
Dura tear during spinal surgery; Intra-dural tumor; trauma-related dura tear
Exclusion:
previous surgery and dura tear in the same location; history of chemotherapy or radiotherapy; malnutrition; uncontrolled metabolic disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-08-31, 1393/06/09
Ethics committee reference number
93-ص-130-1144
Health conditions studied
1
Description of health condition studied
Dura damage
ICD-10 code
G97.0
ICD-10 code description
Cerebrospinal fluid leak from spinal puncture
Primary outcomes
1
Description
CSF leakage
Timepoint
Daily until 8 weeks post discharge
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:
1. Acetazolamide oral tablet; 20 mg/kg/day in 3-4 daily doses for 7 days post surgery
2. Patient in position 3/4 lateral
Category
Treatment - Drugs
2
Description
Control:
1. Patient in position 3/4 lateral
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Alireza Khoshnevisan MD
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical care department-Shariati Hospital
Full name of responsible person
Mohammadreza Javadi
Street address
Jalal-Al-Ahmad Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical care department-Shariati Hospital
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
Shariati Hospital
Full name of responsible person
Elham Amini PharmD
Position
Pharmacist, Pharmaceutical care department/Neurosurgery department
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 8490 2272
Fax
Email
elhamamini.pharm@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shariati hospital
Full name of responsible person
Alireza Khoshnevisan MD
Position
Neuro-surgeon
Other areas of specialty/work
Street address
Shariati hospital
City
Tehran
Postal code
Phone
+98 21 8822 0040
Fax
Email
akhoshnevisan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Center for Rational Use of Drugs
Full name of responsible person
Amir Sarayani PharmD
Position
PharmD, MPH
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
a-sarayanib@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)