Protocol summary

Summary
The aim of this study was to compare the hemodynamic changes in patients undergoing lumbar discopathy surgery between two continuous infusions of Dexmedetomidine and remifentanil during anesthesia with controlled low blood pressure, which was designed as a randomized, triple-blind clinical trial. In this study, the patient, clinician and the person responsible for the statistical analysis will be blind regarding the study groups. Inclusion criteria are patients undergoing lumbar discopathy surgery in physical conditions I and II, and exclusion criteria including any kind of bleeding or coagulation disorders, history of uncontrolled or severe hypertension, use of anticoagulant drugs, history of lumbar discopathy surgery and history of trauma to the lumbar spine. A total of 60 patients aged 20-65 years will be randomly assigned to control and intervention groups. computerized random numbers will be used for randomization. The study method is that for the general anesthesia, the same drug regimen will be used for both groups, and in the intervention group, the dose of Dexmedetomidine is 0.7-0.3 micrograms per kilogram body weight per hour plus propofol of 150-50 micrograms per kilogram of body weight per minute will be continuously injected. In the control group, 1-0.1 μg of Remifentanil per kg body weight per minute plus the same amount of propofol is injected with the same quality. The primary variables of this study are changes in the patient's blood pressure, the amount of patient's bleeding during surgery, and the amount of urinary output. Secondary variables are the time interval between extubation and complete consciousness, the duration of the surgery, and the time that there is a need to administer analgesic drugs after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017083136009N1
Registration date: 2017-11-07, 1396/08/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-07, 1396/08/16
Registrant information
Name
Seyed Alireza Monajjem Zadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 7543
Email address
salirezam82@yahoo.com
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparision of hemodynamic changes between Dexmedetomidine infusion and Remifantanil infusion for controlled hypotensive anesthesia in lumbar discopathy surgery
Public title
A comparison between changes in cardio-vascular variables with the methode of continuous infusion of Dexmedetomidine and Remifentanil for controlled hypotensive anesthesia in lumbar discopathy surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with lumbar discopathy of physical state I and II. Exclusion criteria: any blood disorders and coagulative disorders; history of uncontrolled high blood pressure; taking anti-coagulative drugs; history of lumbar discopathy surgery; history of lumbar trauma
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Ahvaz Jundishapur University of Medical Sciences
Street address
Research Deputy, Ahvaz Jundishapur University of Medical Sciences, Daneshgah Square, Ahvaz
City
Ahvaz
Postal code
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.AJUMS.REC.1396.311

Health conditions studied

1

Description of health condition studied
Lumbar discopathy
ICD-10 code
M51
ICD-10 code description
Other intervertebral disc disorders

Primary outcomes

1

Description
Blood pressure
Timepoint
Before the surgery, during the surgery, after the surgery
Method of measurement
Invasive arterial blood pressure monitoring

2

Description
bleeding
Timepoint
Before the surgery, during the surgery, after the surgery
Method of measurement
Calculation the amount of bleeding: the blood in the bottle of the suction machine in addition to the blood in the gases

3

Description
Urinary output
Timepoint
Before the surgery, during the surgery, after the surgery
Method of measurement
The volume of urine accumulated in the urine bag

Secondary outcomes

1

Description
The interval between extubation and complete consciousness
Timepoint
After the surgery
Method of measurement
observation

2

Description
duration of the surgery
Timepoint
After the surgery
Method of measurement
observation

3

Description
The time that there is a need to prescribe an analgesic
Timepoint
After the surgery
Method of measurement
observation

Intervention groups

1

Description
Intervention group: continuous infusion of Dexmedetomidine , 0.7-0.3 μg per kg body weight per hour plus continuous infusion of propofol, 150-50 μg per kg body weight per minute
Category
Treatment - Drugs

2

Description
Control group: Continuous infusion of Remifentanil, 1-0.1 micro-grams per kg body weight per hour plus continuous infusion of propofol, 150-50 micro-grams per kilogram body weight per minute
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Mahdis Vakili
Street address
Golestan Hospital, Golestan alley, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. SHrif Makhmal Zadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, Daneshgah Square, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahdis Vakili
Position
Consultant
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Daneshgah Square, Ahvaz
City
Ahvaz
Postal code
Phone
+98 916 830 0423
Fax
Email
mahdisvakili@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyed Alireza Monajjemzadeh
Position
Anesthesiology Assistant
Other areas of specialty/work
Street address
Golestan Hospital, Golestan alley, Ahvaz
City
Ahvaz
Postal code
Phone
+98 912 205 7826
Fax
Email
Salirezam82@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahdis Vakili
Position
Consultant
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Daneshgah Square, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
mahdisvakili@ymail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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