View older revisions Content changed at 2023-05-29, 1402/03/08

Protocol summary

Study aim
Comparison of the effects of general anesthesia and regional anesthesia in the clinical outcome of spinal surgery
Design
A randomized clinical trial with parallel group design on 100 patients.
Settings and conduct
Patients admitted to the neurosurgery ward of Imam Hossein Hospital in Tehran admitted with a diagnosis of discopathy and no pedicle screw indication Informed consent for both methods includes general anesthesia or regional anesthesia.
Participants/Inclusion and exclusion criteria
All patients with spinal discopathy who need surgery for the first time and have no history of hepatic, renal, and pulmonary failure, and the presence of any coagulopathy
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; acetaminophen dose usage

General information

Reason for update
To clarify to more extent, literary corrections were made.
Acronym
IRCT registration information
IRCT registration number: IRCT20210722051955N1
Registration date: 2021-08-07, 1400/05/16
Registration timing: prospective

Last update: 2023-05-29, 1402/03/08
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 regional anesthesia in clinical outcome of lumbar spine surgery
Public title
A comparative study of general anesthesia vs regional anesthesia in spinal surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with discopathy who need surgery Signing a written consent to enter the study Spinal surgery for the first time
Exclusion criteria:
Pedicle screw indication Renal, hepatic or pulmonary 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 enrolled in the study will given a random number and through a randomized table will be divided into 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 University of Medical Sciences
Street address
SBMU. Daneshjoo Blvd., Darakeh
City
Tehran
Province
Tehran
Postal code
1985717443
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
Operation duration
Timepoint
Start and end point of the surgery
Method of measurement
Time based on minutes

Secondary outcomes

1

Description
Blood loss
Timepoint
Before surgery and the point of discharge
Method of measurement
Hemoglobin and volume of drainage

2

Description
Pain
Timepoint
After surgery
Method of measurement
Used paracetamol in gram

3

Description
Vital signs
Timepoint
Before procedure, Prone position, Supine position
Method of measurement
Heart Rate , Blood Pressure

4

Description
Nausea/Vomiting
Timepoint
After surgery
Method of measurement
Used antiemetic and subjective patient complaint

Intervention groups

1

Description
Intervention group: Regional anesthesia with epidural injection of Pethidine 1mg/kg (Aburaihan 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 Hossein 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
Dr. Ali Ziae
Street address
Shahid Beheshti Medical University, Arabi St, Daneshgah Blvd., Darake
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 Hossein 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 Hossein 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 Hossein 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
1 week after email reception
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