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Comparison of general anesthesia and regional anesthesia in clinical outcome of lumbar spine surgery

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History
# Registration date Revision Id
2 2023-05-29, 1402/03/08 266325
1 2021-08-07, 1400/05/16 193136
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  • Protocol summary

    Comparison of effects of general anesthesia and topical anesthesia in clinical outcome of lumbar spine surgery
    Comparison of the effects of general anesthesia and regional anesthesia in the clinical outcome of spinal surgery
    بررسی تاثیر روش بیهوشی عمومی و بی حسی موضعی در عاقبت بالینی بیماران جراحی ستون فقرات کمری
    بررسی تاثیر روش بیهوشی عمومی و بی حسی منطقه ای در عاقبت بالینی بیماران جراحی ستون فقرات کمری
    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.
    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.
    بیماران بستری در بخش جراحی اعصاب بیمارستان امام حسین تهران با تشخیص دیسکوپاتی کمر که نیاز به وسیله گذاری ندارند و رضایت اگاهانه نسبت به انجام هر 2 نوع روش جراحی شامل بیهوشی عمومی و بی حسی موضعی دارند
    بیماران بستری در بخش جراحی اعصاب بیمارستان امام حسین تهران با تشخیص دیسکوپاتی کمر که نیاز به وسیله گذاری ندارند و رضایت اگاهانه نسبت به انجام هر 2 نوع روش جراحی شامل بیهوشی عمومی و بی حسی منطقه ای دارند
    All patients with lumbar discopathy who need surgery for first time and dosnt have liver failure, pulmonary failure, and coagolopathy
    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
    تمام بیماران دیسکوپاتی کمری کاندید جراحی که برای اولین بار تحت عمل جراحی قرار میگیرند و نیازمند وسیله گذاری نیستند و بیماری زمینه ای کبد و کلیه و اختلال انعقادی ندارند
    تمام بیماران دیسکوپاتی کمری کاندید جراحی که برای اولین بار تحت عمل جراحی قرار میگیرند و نیازمند وسیله گذاری نیستند و بیماری زمینه ای کبد و کلیه و ریوی و اختلال انعقادی ندارند
    نیمی از بیماران تحت بیهوشی عمومی و نیمی تحت بی حسی موضعی قرار میگیرند
    نیمی از بیماران تحت بیهوشی عمومی و نیمی تحت بی حسی منطقه ای قرار میگیرند
    Oswestry disability index; bleeding volume during and after surgery; surgery duration; anesthesia duration; analgesic dose usage
    Oswestry disability index; bleeding volume during and after surgery; surgery duration; anesthesia duration; acetaminophen dose usage
    میزان ناکارامدی بر حسب معیار ODI - میزان خونریزی حین و بعد از عمل - طول مدت جراحی- طول مدت بیهوشی - میزان مصرف داروی ضد درد
    میزان ناکارامدی بر حسب معیار ODI - میزان خونریزی حین و بعد از عمل - طول مدت جراحی- طول مدت بیهوشی - میزان مصرف داروی ضد درد استامینوفن

  • General information

    empty
    To clarify to more extent, literary corrections were made.
    empty
    برای شفافیت بیشتر، اصلاحات نگارشی انجام شد.
    Study on general anesthesia in lumbar spine surgery. Study on topical anesthesia in lumbar spine surgery.
    A comparative study of general anesthesia vs regional anesthesia in spinal surgery.
    بررسی اثر بیهوشی عمومی در جراحی ستون فقرات. بررسی اثر بی حسی موضعی در جراحی ستون فقرات.
    بررسی اثر بیهوشی عمومی در مقابل بی حسی منطقه ای در جراحی ستون فقرات.
    Comparison of general anesthesia and topical anesthesia in clinical outcome of lumbar spine surgery
    Comparison of general anesthesia and regional anesthesia in clinical outcome of lumbar spine surgery
    مقایسه روش بیهوشی عمومی و بی حسی موضعی در عاقبت بالینی بیماران جراحی ستون فقرات کمری
    مقایسه روش بیهوشی عمومی و بی حسی منطقه ای در عاقبت بالینی بیماران جراحی ستون فقرات کمری
    Patients with lumbar discopathy who need surgery
    Satisfaction
    Lumbar surgery for first time
    Patients with discopathy who need surgery
    Signing a written consent to enter the study
    Spinal surgery for the first time
    دیسکوپاتی کمر نیازمند جراحی
    رضایت آگاهانه برای ورود به تحقیق
    جراحی نوبت اول
    دیسکوپاتی کمر نیازمند جراحی
    امضا رضایت نامه کتبی جهت ورود آگاهانه به مطالعه
    جراحی نوبت اول
    Pedicle screw indication
    Kidney or liver failure
    Coagolopathy
    Contraindication for regional anesthesia
    Pedicle screw indication
    Renal, hepatic or pulmonary failure
    Coagolopathy
    Contraindication for regional anesthesia
    نیازمند وسیله گذاری
    نارسایی کلیه و کبد
    اختلال انعقادی
    کنتراندیکاسیون بی حسی منطقه ای
    نیازمند وسیله گذاری
    نارسایی کلیه، کبد یا ریه
    اختلال انعقادی
    هر نوع کنتراندیکاسیون برای انجام بی حسی منطقه ای
    All patients who inserted in study; by random number table and number of entrance and randomized table divided in 2 groups.
    All patients who enrolled in the study will given a random number and through a randomized table will be divided into 2 groups.
    بیمارانی که وارد مطالعه میشوند برحسب ترتیب ورود به مطالعه دارای شماره میشوند و بکمک جدول اعداد تصادفی به 2گروه تقسیم میشوند.
    بیمارانی که وارد مطالعه میشوند برحسب ترتیب ورود به مطالعه دارای شماره میشوند و بکمک جدول اعداد تصادفی به 2 گروه تقسیم میشوند.

  • Primary outcomes

    #1
    Post operation outcome like bleeding and pain and ...
    Operation duration
    پیامدهای حین و بعد از عمل از جمله خونریزی و درد و ...
    طول عمل
    Before operation, 1 day after operation, 1 month after operation
    Start and end point of the surgery
    قبل عمل. روز بعد از عمل. یک ماه بعد از عمل
    ابتدا و انتهای عمل
    Pain with ODI; bleeding with cc; analgesic with gr
    Time based on minutes
    درد با معیار ODI- خونریزی بر حسب cc - میزان دریافت مسکن برحسب gr
    زمان بر حسب دقیقه

  • Secondary outcomes

    #1
    empty
    Blood loss
    empty
    خون ریزی
    empty
    Before surgery and the point of discharge
    empty
    قبل عمل و در انتهای ترخیص
    empty
    Hemoglobin and volume of drainage
    empty
    هموگلوبین و مقدار خروجی از درن
    #2
    empty
    Pain
    empty
    درد
    empty
    After surgery
    empty
    بعد از عمل جراحی
    empty
    Used paracetamol in gram
    empty
    میزان استامینوفن مصرفی بر حسب گرم
    #3
    empty
    Vital signs
    empty
    علایم حیاتی
    empty
    Before procedure, Prone position, Supine position
    empty
    قبل عمل در حالت خوابیده به جلو در حالت خوابیده به پشت
    empty
    Heart Rate , Blood Pressure
    empty
    تعداد ضربان قلب، میزان فشار خون
    #4
    empty
    Nausea/Vomiting
    empty
    تهوع و استفراغ
    empty
    After surgery
    empty
    بعد از جراحی
    empty
    Used antiemetic and subjective patient complaint
    empty
    میزان داروی ضد تهوع استفاده شده و خود اظهاری بیمار

  • Intervention groups

    #1
    Intervention group: Regional anesthesia with epidural injection of Pethedine 1mg/kg (abureihan co) and intravenous injection of Dexmedetomidine 0.2μg/kg (Exir co)
    Intervention group: Regional anesthesia with epidural injection of Pethidine 1mg/kg (Aburaihan co) and intravenous injection of Dexmedetomidine 0.2μg/kg (Exir co)

  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Hussein hospital
    Name of recruitment center - Persian: بیمارستان امام حسین
    Full name of responsible person - English: Ahmadreza Vahdati
    Full name of responsible person - Persian: احمدرضا وحدتی
    Street address - English: Madani st. Nezam abad. Tehran
    Street address - Persian: تهران. نظام آباد. خ شهید مدنی. بیمارستان امام حسین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Fax:
    Email: info@ehmc.ir
    Web page address:
    Name of recruitment center - English: Imam Hossein hospital
    Name of recruitment center - Persian: بیمارستان امام حسین
    Full name of responsible person - English: Ahmadreza Vahdati
    Full name of responsible person - Persian: احمدرضا وحدتی
    Street address - English: Madani st. Nezam Abad. Tehran
    Street address - Persian: تهران. نظام آباد. خ شهید مدنی. بیمارستان امام حسین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Fax:
    Email: info@ehmc.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: دکتر حمیدرضا خیاط کاشانی
    Full name of responsible person - Persian: Dr. hamidreza khayat kashani
    Street address - English: Shahid beheshti medical university. daneshgah Blvd. Darake. Tehran
    Street address - Persian: تهران. درکه. بلوار دانشگاه. دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717443
    Phone: +98 21 23871
    Fax:
    Email: info@sbmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Ali Ziae
    Full name of responsible person - Persian: دکتر علی ضیایی
    Street address - English: Shahid Beheshti Medical University, Arabi St, Daneshgah Blvd., Darake
    Street address - Persian: تهران. درکه. بلوار دانشگاه. خ شهید اعرابی. دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717443
    Phone: +98 21 23871
    Fax:
    Email: info@sbmu.ac.ir
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ahmadreza Vahdati
    Full name of responsible person - Persian: احمدرضا وحدتی
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 37
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Hussein hospital. Madani st. Tehran
    Street address - Persian: تهران. شهید مدنی. بیمارستان امام حسین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Mobile: +98 912 283 6783
    Fax:
    Email: Ahmadreza.vahdati@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ahmadreza Vahdati
    Full name of responsible person - Persian: احمدرضا وحدتی
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 37
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Hossein hospital. Madani st. Tehran
    Street address - Persian: تهران. شهید مدنی. بیمارستان امام حسین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Mobile: +98 912 283 6783
    Fax:
    Email: Ahmadreza.vahdati@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamidreza khayat kashani
    Full name of responsible person - Persian: حمیدرضا خیاط کاشانی
    Position - English: Associate professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 37
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Hussein Hospital. Madani st. Tehran
    Street address - Persian: تهران. خ شهید مدنی. بیمارستان امام حسین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Mobile: +98 913 162 5625
    Fax:
    Email: hamidkhayat@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamidreza Khayat Kashani
    Full name of responsible person - Persian: حمیدرضا خیاط کاشانی
    Position - English: Associate professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 37
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Hossein Hospital. Madani st. Tehran
    Street address - Persian: تهران. خ شهید مدنی. بیمارستان امام حسین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Mobile: +98 913 162 5625
    Fax:
    Email: hamidkhayat@yahoo.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ahmadreza Vahdati
    Full name of responsible person - Persian: احمدرضا وحدتی
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 37
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Hussein Hospital. Madani st. Tehran
    Street address - Persian: تهران. خ شهید مدنی. بیمارستان امام حسین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Mobile: +98 912 283 6783
    Fax:
    Email: Ahmadreza.vahdati@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ahmadreza Vahdati
    Full name of responsible person - Persian: احمدرضا وحدتی
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 37
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Hossein Hospital. Madani st. Tehran
    Street address - Persian: تهران. خ شهید مدنی. بیمارستان امام حسین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1617763141
    Phone: +98 21 7343 0000
    Mobile: +98 912 283 6783
    Fax:
    Email: Ahmadreza.vahdati@gmail.com
    Web page address:

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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