Effect of ephedrine infusion on hemodynamic changes in the elderly undergoing spinal anesthesia
Design
This is a randomized, single-blind clinical trial with parallel and control groups.
Settings and conduct
Patients will receive appropriate intervention at Imam Reza Hospital in Tabriz after being assigned to the relevant groups. Patients in the intervention group during spinal anesthesia will receive ephedrine after infusion and the control group will receive the placebo. Patients are blind during the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Minimum age 65 years,
Candidate for Spinal Anesthesia
Exclusion criteria:
Diabetes Mellitus,
Cardiovascular disease
Intervention groups
Participants will be randomly divided into two groups; anesthesia for all individuals in the fourth and fifth lumbar spines will be done:
Intervention group: After blood pressure drop of more than 20%, they will receive vasopressor drug and will be given ephedrine infusion.
Control group: After a blood pressure drop of more than 20%, they will receive placebo (normal saline serum) and given placebo as an infusion. Normal saline serum is manufactured by Iran Darou Company.
It should be noted that ephedrine or placebo will be infused at 60 mg / hr. Ephedrine is a medicine manufactured by Iran Darou Company and infusion is started each time the patient's blood pressure drops and if healed, the infusion will be stopped. The infusion pump machine will be used to do this, which is a device manufactured by Zimmer in the US.
Main outcome variables
Blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N15
Registration date:2019-12-22, 1398/10/01
Registration timing:prospective
Last update:2019-12-22, 1398/10/01
Update count:0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ephedrine infusion on hemodynamic changes in the elderly undergoing spinal anesthesia
Public title
Ephedrine infusion during spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age 65 years
Candidate for spinal anesthesia
Exclusion criteria:
Cardiovascular diseases
Diabetes Mellitus
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The dice throw method will be used for randomization. The even number represents the individual in the intervention group and the odd number represents the individual in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants will be given drug infusions or placebo (normal saline serum) in case of hypotension. The drug or placebo will be 50mm inside the syringe. The syringes are quite similar and their contents are colorless. The participant is unaware of the type of drug received and will be blind during the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-10-04, 1398/07/12
Ethics committee reference number
IR.TBZMED.REC.1398.733
Health conditions studied
1
Description of health condition studied
Blood pressure
ICD-10 code
R03.0
ICD-10 code description
Elevated blood-pressure reading, without diagnosis of hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
After spinal anesthesia, the patient's blood pressure will be measured every three minutes.
Method of measurement
Barometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in this group will be randomly assigned to spinal anesthesia after random assignment. In the first ten minutes, blood pressure will be measured every 1 minute and then every three minutes. If blood pressure drops below 20%, the infusion of ephedrine in the 50-mm syringe will begin at a rate of three milliliters per hour and will continue until the blood pressure returns to normal. During surgery, if the blood pressure drops more than 20%, the drug will be infused. The dose will be 60 mg per hour. The drug will be purchased from Iran Daroo Company .
Category
Treatment - Drugs
2
Description
Control group: Participants in this group will be randomly assigned to spinal anesthesia after random assignment. In the first ten minutes, blood pressure will be measured every 1 minute and then every three minutes. If blood pressure drops below 20%, placebo infusion will begin in a 50-mm syringe at a rate of three milliliters per hour and will continue until the blood pressure returns to normal. During surgery, if the blood pressure drops more than 20%, the placebo will be infused. In our study, placebo is a normal saline serum that will be purchased from Iran Daroo Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Parichehr Mazooji
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
parimaz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Parichehr Mazoji
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Iman Reza Hospital, Golgash Ave
City
East Azarbaijan
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3336 9586
Email
parimaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parichehr Mazoji
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Parimaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parichehr Mazoji
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Parimaz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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