Comparing the effect of dexmetedomidine and remifentanil on controlled hypotension in patients undergoing general anesthesia candidates for spine surgery
A double-blind clinical trial in two groups of dexmedetomidine and remifentanil (35 people in each group) randomly based on random numbers generated using Random Allocation computer software.
Settings and conduct
Patients in Imam Khomeini Hospital will be randomly divided into two groups: dexmedetomidine and remifentanil. The patient and the trained technician will be responsible for recording the patients' data and will not be informed about the grouping of the drugs used. The dose of remifentanil and dexmedetomidine (1-0.1) micrograms/kg of body weight per minute until the end of the surgery will be nitroglycerin (TNG) infusion at the rate of 5 micrograms per minute so that the patient's blood pressure reaches the range of SBP between 80-100 mm Hg. More than 20 At first, the base percentage of propofol will be reduced by the same amount, and if necessary, the dose of dexmedetomidine or remifentanil will be reduced in two groups with the same protocol.
Participants/Inclusion and exclusion criteria
Entering into the study adult patients with ASA I-II status undergoing spine surgery under anesthesia and not including patients who need emergency surgery, pregnant people, patients with a history of spine surgery, history of opioid use, drug abuse or alcohol addiction, history nervous diseases, Neuromuscular or psychiatric (especially history of seizures or epilepsy), history of heart failure, patients with cardiac bradycardia, long-term and chronic use of painkillers including cyclooxygenase 2 inhibitors, patients with unpredictable events Heavy bleeding
Intervention groups
Dexmedetomidine group and Remifentanil group
Main outcome variables
Hypotension control in spine surgery patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241108063640N2
Registration date:2024-11-15, 1403/08/25
Registration timing:prospective
Last update:2024-11-15, 1403/08/25
Update count:0
Registration date
2024-11-15, 1403/08/25
Registrant information
Name
hadi Hooshyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
hooshyarhadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-20, 1403/09/30
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of dexmetedomidine and remifentanil on controlled hypotension in patients undergoing general anesthesia candidates for spine surgery
Public title
Comparing the effect of dexmetedomidine and remifentanil on controlled hypotension in patients undergoing general anesthesia candidates for spine surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria included adult patients with ASA I-II status undergoing spine surgery under general anesthesia
Completion of the informed consent form for participating in the study
Exclusion criteria:
Patients who need emergency surgery
Pregnant people
Patients with a history of spine surgery
History of opioid use Drug abuse or alcohol addiction
History of neurological diseases
Neuromuscular or psychiatric (especially history of seizures or epilepsy)
History of heart failure
patients with cardiac bradycardia
Long-term and chronic use of pain relievers, including cyclooxygenase 2
inhibitorsPatients with unpredictable events such as severe bleeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups based on random numbers generated using Random Allocation computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the trained technician are responsible for recording the patients' data and will not be informed about the grouping of the drugs used.
Placebo
Not used
Assignment
Parallel
Other design features
. Adult patients with ASA I-II status undergoing spinal surgery under general anesthesia in Imam Khomeini Hospital Urmia will be included in the study. Then the patients will be divided into two groups of dexmedetomidine and remifentanil (35 people in each group) using the table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Approval date
2024-10-02, 1403/07/11
Ethics committee reference number
IR.UMSU.HIMAM.REC.1403.084
Health conditions studied
1
Description of health condition studied
Adult patients with ASA I-II status undergoing spine surgery under general anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Systolic and diastolic blood pressure control
Timepoint
(before induction), t1 (after induction), t2 (after incision), t3 (15 minutes after surgery), t9 (90 minutes after surgery), R0 (entering the recovery room) and R30 (30 minutes after from entering the recovery room)
Method of measurement
by a non-invasive sphygmomanometer for anesthesia monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dexmedetomidine group
Category
Treatment - Drugs
2
Description
Intervention group: Fentanyl withdrawal group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Urmia
Full name of responsible person
Dr.Hadi hooshyar
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
hooshyarhadi@gmail.com
Web page address
http://Imam.umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Resalat Boulevard - Emergency Alley - Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
sabergholizadeh@yahoo.com
Web page address
https://Umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Hadi Hooshyar
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
hooshyarhadi@gmail.com
Web page address
http://Imam.umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Hadi Hooshyar
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
hooshyarhadi@gmail.com
Web page address
http://Imam.umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Hadi Hooshyar
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Fax
+98 44 3345 7277
Email
hooshyarhadi@gmail.com
Web page address
http://Imam.umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available