Comparison of effects of general anesthesia and topical anesthesia in clinical outcome of lumbar spine surgery
Design
A randomized clinical trial with parallel group design on 100 patients.
Settings and conduct
Patients who admitted in neurosurgery ward of Immam Hussein hospital of Tehran
admitted by lumbar discopathy diagnosis and dont need fixation.
Informed consent for both method include general anesthesia or topical anesthesia.
Participants/Inclusion and exclusion criteria
All patients with lumbar discopathy who need surgery for first time and dosnt have liver failure, pulmonary failure, and coagolopathy
Intervention groups
50% of patients take general anesthesia and 50% take regional anesthesia
Main outcome variables
Oswestry disability index; bleeding volume during and after surgery; surgery duration; anesthesia duration; analgesic dose usage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210722051955N1
Registration date:2021-08-07, 1400/05/16
Registration timing:prospective
Last update:2021-08-07, 1400/05/16
Update count:1
Registration date
2021-08-07, 1400/05/16
Registrant information
Name
Ahmadreza Vahdati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2613 4479
Email address
s_bargozideh@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of general anesthesia and topical anesthesia in clinical outcome of lumbar spine surgery
Public title
Study on general anesthesia in lumbar spine surgery. Study on topical anesthesia in lumbar spine surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lumbar discopathy who need surgery
Satisfaction
Lumbar surgery for first time
Exclusion criteria:
Pedicle screw indication
Kidney or liver failure
Coagolopathy
Contraindication for regional anesthesia
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
All patients who inserted in study; by random number table and number of entrance and randomized table divided in 2 groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti medical university
Street address
Imam hussein hospital. Madani st. Nezam abad. Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2021-02-16, 1399/11/28
Ethics committee reference number
IR.SBMU.MSP.REC.1399.716
Health conditions studied
1
Description of health condition studied
Lumbar discopathy
ICD-10 code
M51.1
ICD-10 code description
Thoracic, thoracolumbar and lumbosacral intervertebral disc disorder with radiculopathy
Primary outcomes
1
Description
Post operation outcome like bleeding and pain and ...
Timepoint
Before operation, 1 day after operation, 1 month after operation
Method of measurement
Pain with ODI; bleeding with cc; analgesic with gr
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Regional anesthesia with epidural injection of Pethedine 1mg/kg (abureihan co) and intravenous injection of Dexmedetomidine 0.2μg/kg (Exir co)
Category
Treatment - Surgery
2
Description
Control group: In General anesthesia group . Induction with Propofol 2mg/kg and Fentanyl 4mg/kg (Caspian co) and Maintenance with Isoflurane (Baxter co).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein hospital
Full name of responsible person
Ahmadreza Vahdati
Street address
Madani st. Nezam abad. Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Fax
Email
info@ehmc.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
دکتر حمیدرضا خیاط کاشانی
Street address
Shahid beheshti medical university. daneshgah Blvd. Darake. Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmadreza Vahdati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Imam Hussein hospital. Madani st. Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
Ahmadreza.vahdati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamidreza khayat kashani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Hussein Hospital. Madani st. Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
hamidkhayat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmadreza Vahdati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Imam Hussein Hospital. Madani st. Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
Ahmadreza.vahdati@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information is publishable except names of patients.
When the data will become available and for how long
1 year after publish
To whom data/document is available
Everyone
Under which criteria data/document could be used
Unlimited
From where data/document is obtainable
Personal email
What processes are involved for a request to access data/document