Comparison of the effect of norepinephrine and phenylephrine infusion for the prevention of hypotension during spinal anesthesiain patients undergoing hip fracture surgery.
Comparison of the effect of norepinephrine infusion versus phenylephrine in preventing hemodynamic changes following spinal anesthesia in patients undergoing hip fracture surgery.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2-3 on 125 patients. www.sealedenvelope.com is used for randomization.
Settings and conduct
This double-blind clinical trial study will be conducted on 125 patients undergoing hip fracture surgery in two groups at Sina Hospital in Tehran. Random allocation of samples is done by block method. A digital monitor will be used to measure blood pressure and heart rate. Questionnaires will be completed and variables will be recorded by the research team during the operation and at the designated times.
Participants/Inclusion and exclusion criteria
Conditions for entering the study include: patients over 50 years of age who are candidates for hip fracture surgery, who can receive spinal anesthesia according to the anesthesiologist's opinion and are willing to undergo spinal anesthesia. Conditions for exclusion from the study: the patient's inability to be in the right position or the presence of any contraindications for spinal anesthesia and the need for general anesthesia according to the anesthesiologist's opinion and failure of spinal anesthesia.
Intervention groups
Intervention group: patients who receive intravenous infusion of epinephrine (8µg/min) immediately after spinal anesthesia until the end of the operation. Control group: patients who receive intravenous phenylephrine infusion (50 µg /min) immediately after spinal anesthesia until the end of the operation.
Comparison of the effect of norepinephrine and phenylephrine infusion for the prevention of hypotension during spinal anesthesiain patients undergoing hip fracture surgery.
Public title
Comparison of the effect of norepinephrine and phenylephrine infusion for the prevention of hypotension during spinal anesthesia for patients undergoing hip fracture surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing hip fracture surgery who need spinal anesthesia according to the anesthesiologist's opinion
Age older 50 years old
Patient's consent to perform spinal anesthesia
Exclusion criteria:
The patient's inability to be in the right position or the presence of any contraindications for spinal anesthesia
The need for general anesthesia according to the anesthesiologist
Failure of spinal anesthesia
Age
From 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
125
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used for the random allocation of patients,and the website www.sealedenvelope.com will be used.The website creates blocks randomly (keeping in mind that the number of study groups in each block is equal) and the number of generated blocks will be 35.Then he provides them as an Excel output to the random person. Only the anesthesiologist knows about the grouping of the patients and prepares the medicine needed for each group anonymously in the microset and provides it to the anesthesiologist (project manager).Enrollment in the study is determined based on the blocks made in order.For example, if the first quadruple block generated is norepinephrine/phenylephrine/phenylephrine/norepinephrine, the first and fourth patients are entered into the norepinephrine group and the second and third patients are entered into the phenylephrine group.The determination of the group was done by the anesthesiologist and the researchers will not know about this process and the structure of the blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researched drugs are similar in color and are prepared anonymously with a special code by a nurse of anesthesia who is not involved in the research team.She records the syringe code, date, and patient file number in her notebook and keeps it with her until the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Sina Hospital, Tehran University of Medical Sciences
Street address
Sinai Hospital, Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2022-08-02, 1401/05/11
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1401.053
Health conditions studied
1
Description of health condition studied
Hypotension after spinal anesthesia
ICD-10 code
I95.81
ICD-10 code description
Postprocedural hypotension
Primary outcomes
1
Description
Blood pressure
Timepoint
Every 3 minutes
Method of measurement
Digital pressure gauge
2
Description
Heart Rate
Timepoint
Continuously
Method of measurement
ECG monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After spinal anesthesia for hip surgery, intravenous infusion of norepinephrine 5 micrograms per minute is started.
Category
Prevention
2
Description
Control group: After spinal anesthesia for hip surgery, intravenous infusion of phenylephrine 50 μg/min is started.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mohammad Reza Neishaburi
Street address
Sinai Hospital, Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Email
mrneishaboury@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fatuhi
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Neishaboury
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sinai Hospital,Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Email
mrneishaboury@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Neishaboury
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sinai Hospital,Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Email
mrneishaboury@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Neishaboury
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sinai Hospital,Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Email
mrneishaboury@tums.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Main outcome data of the study
When the data will become available and for how long
6 months after completing the study
To whom data/document is available
University researchers
Under which criteria data/document could be used
Sharing scientific findings to increase the production of science
From where data/document is obtainable
Email address of Dr. Nishaboury:mrnishaboury@tums.ac.ir
What processes are involved for a request to access data/document
The request should be made by email and the answer will be given within two months