Evaluating the effect of administration of intrathecal Dexmedetomidine on the Spinal Cord Mori levels of apoptotic factors in patients scheduled for lumbar disc surgery
Evaluating the effect of administration of intrathecal Dexmedetomidine on the Spinal Cord Mori levels of apoptotic factors in patients scheduled for lumbar disc surgery
Design
Randomized, Not blinded, controlled, parallel group phase lll clinical trial in 40 patients
Settings and conduct
This study was performed on patients with lumbar disc herniation who were referred to Loghman Hakim Hospital for surgery randomly in two groups after signing consent. After surgical incision and reaching about 1 cc of cerebrospinal fluid, the insulin needle remains in place in the dexmedetomidine group and the syringe is removed.with another syringe Dexmedetomidine is injected into the intrathecal space. Finally, 1 cc of cerebrospinal fluid is taken again. But in the control group, the needle is removed.Then, the sample factors will be measured by ELISA in both groups at the beginning and end of surgery and their results will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-60; No history of taking anti-inflammatory drugs two weeks before surgery; Lack of AIDS and immunosuppressive diseases. Exclusion criteria: GCS reduction for a reason other than stroke; Change in the type of surgery according to the surgeon's opinion; History of systemic diseases such as diabetes
Intervention groups
Intervention group: After surgical incision a spinal cord fluid sample of 1 cc is taken from the site of surgery, the needle stays in place and the syringe is removed and with another syringe Dexmedetomidine is injected intrathecally. Control group: After surgical incision a spinal cord fluid sample of 1 cc is taken from the site of surgery And the needle comes out. At the end, 1 cc of cerebrospinal fluid is again taken from both groups.
Main outcome variables
Bax/Bcl-2 and caspase-3 apoptotic factor levels in cerebrospinal fluid after initiation and at the end of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N1
Registration date:2020-04-19, 1399/01/31
Registration timing:registered_while_recruiting
Last update:2020-04-19, 1399/01/31
Update count:0
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of administration of intrathecal Dexmedetomidine on the Spinal Cord Mori levels of apoptotic factors in patients scheduled for lumbar disc surgery
Public title
effect of administration of intrathecal Dexmedetomidine on the Spinal Cord Mori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of taking anti-inflammatory drugs two weeks before surgery
Lack of AIDS and immunosuppressive diseases
Exclusion criteria:
GCS reduction for a reason other than stroke
Change in the type of surgery according to the surgeon's opinion
History of systemic diseases such as diabetes mellitus, renal failure and chronic pulmonary heart disease
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients included in the study will be randomly divided into control and Dexmedetomidine groups based on random number table.In this way, we put a set of numbers in a completely random order without any pattern or order, set the table numbers to read from above. For intervention group we consider even numbers and for control group we consider individual numbers. Then we place one of the numbers up and down, register the number and assign it to one of the intervention or control groups.
Blinding (investigator's opinion)
Not 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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yaman Street, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.SBMU.MSP.REC.1398.098
Health conditions studied
1
Description of health condition studied
Lumbar disc herniation
ICD-10 code
M51
ICD-10 code description
Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders
Primary outcomes
1
Description
The level of Bax / Bcl-2¬ apoptotic factor in cerebrospinal fluid in dexmedetomidine and placebo group
Timepoint
After surgery and at the end of surgery
Method of measurement
Study of cerebrospinal fluid in dexmedetomidine and placebo group by ELISA
2
Description
Numering Rating Scale (NRS) Pain score in dexmedetomidine and placebo group
Timepoint
Before anesthesia and in recovery
Method of measurement
NRS scoring system
3
Description
The level of caspase-3 apoptotic factor in cerebrospinal fluid in dexmedetomidine and placebo group
Timepoint
After surgery and at the end of surgery
Method of measurement
Study of cerebrospinal fluid in dexmedetomidine and placebo group by ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After surgical incision a spinal cord fluid sample of 1 cc is taken from the site of surgery, the needle stays in place and the syringe is removed and with another syringe Dexmedetomidine is injected intrathecally.Finally, 1 cc of cerebrospinal fluid is taken again.
Category
Treatment - Drugs
2
Description
Control group: After surgical incision a spinal cord fluid sample of 1 cc is taken from the site of surgery And the needle comes out. Finally, 1 cc of cerebrospinal fluid is taken again.