Comparison of the effect of intravenous ephedrine and atropine in the prevention of arterialhypotension and bradycardia after spinal anesthesia parallel clinicaltrial
Determining the effect of intravenous atropine and ephedrine in preventing arterial hypotension or bradycardia in patients who underwent spinal anesthesia.
Design
A clinical trial with a control group with randomized double-blind parallel groups in phase 3 on 156 patients, all patients who meet the inclusion criteria will be randomly divided into three groups using randomization software until the required sample size is completed.
Settings and conduct
This study will be conducted in Shahid Madani Hospital of Karaj.. Before starting spinal anesthesia and drug injection, as well as during surgery, blood pressure and heart rate will be monitored by NIBP method. Candidate patients to participate in the study will have a systolic blood pressure of 100 to 140 and will be placed in groups A and B to receive medicine.Ephedrine 0.15 mg/kg and atropine 0.01 mg/kg immediately before B Spinal anesthesia will be injected separately for the patients of the groups. Distilled water will be used in the control group.
Participants/Inclusion and exclusion criteria
Participants:Surgical candidates aged 18 to 60 years who are undergoing spinal anesthesia.
Inclusion criteria include absence of arterial hypertension, absence of arrhythmia and no bradycardia or tachycardia.
The exclusion criteria include: Taking beta blockers or calcium channel blockers for any reason, taking cardiac drugs and blood pressure drugs, primary systolic blood pressure more than 140 mmHg, tachycardia HR>100 before anesthetic injection, presence of ischemic heart disease, valvular disease Heart disease, hyperthyroidism, sensitivity to ephedrine and atropine, bleeding during surgery is more than 10%.
Intervention groups
Group A (ephedrine recipient) and B group (atropine recipient) and Group C (control or recipient of distilled water)
Comparison of the effect of intravenous ephedrine and atropine in the prevention of arterialhypotension and bradycardia after spinal anesthesia parallel clinicaltrial
Public title
Comparison of the effect of intravenous ephedrine and atropine in the prevention of arterialhypotension and bradycardia after spinal anesthesia parallel clinicaltrial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 18 to 60 years
absence of arterial hypertension
absence of arrhythmia
absence of bradycardia and tachycardia.
Exclusion criteria:
Taking beta blockers or calcium channel blockers for any reason
taking cardiac drugs and blood pressure drugs
primary systolic blood pressure more than 140 mmHg
tachycardia HR>100 before anesthetic injection
presence of ischemic heart disease
Heart valve disease
hyperthyroidism
sensitivity to ephedrine or atropine
bleeding during surgery is more than 10%
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
156
Randomization (investigator's opinion)
Randomized
Randomization description
All patients who meet the criteria for entering the study were randomized into three blocks: ephedrine, atropine and control. Divided in the form of simple random probability sampling to complete the required sample volume, they will be divided into three groups And they will be placed in three groups A (ephedrine recipient), B group (atropine recipient) and C group (control).
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blind, the patient and the anesthesiologist who is the patient's caregiver and nurse, and taking notes Blood pressure and heart rate are their responsibility, they will not know about the type of injectable drugs and placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, Building of the Vice Chancellor for Research and Technology, Safarian Street, 45 Meter Golshahr, Karaj, Iran.
City
Karaj
Province
Alborz
Postal code
۳۱۹۸۷۶۴۶۵۳
Approval date
2024-10-28, 1403/08/07
Ethics committee reference number
IR.ABZUMS.REC.1403.196
Health conditions studied
1
Description of health condition studied
arterial hypotension
ICD-10 code
I95.8
ICD-10 code description
Other hypotension
Primary outcomes
1
Description
arterial hypotension
Timepoint
Patients' blood pressure will be measured at baseline before spinal anesthesia and drug injection, then every 1 minute to 10 minutes, and then every 5 minutes to 45 minutes after drug injection.
Method of measurement
Blood pressure monitoring of patients will be by NIBP (Non Invasive Blood Pressure) method
2
Description
bradycardia
Timepoint
Patients' heart rate will be measured at baseline before spinal anesthesia and drug injection, then every 1 minute to 10 minutes, and then every 5 minutes to 45 minutes after drug injection.
Method of measurement
heart rate monitoring of patients will be by NIBP (Non Invasive Blood Pressure) method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Ephedrine 0.15 mg per kg will be injected immediately before spinal anesthesia for group A patients. The amount of injectable ephedrine per shift will be 0.15 mg/kg per shift until the systolic blood pressure and HR reach the patient's baseline figure. It should be noted that the same drug brand will be used for all patients. During the operation, 500 cc of normal saline will be injected per hour of surgery.Patients' blood pressure and heart rate will be measured at baseline before spinal anesthesia and drug injection, then every 1 minute to 10 minutes, and then every 5 minutes to 45 minutes after drug injection. If the patient's blood pressure drops by more than 20% compared to the baseline value, in the treatment groups, in addition to receiving medication, normal saline will be injected for free.
Category
Prevention
2
Description
Intervention group B: Atropine 0.01 mg per kg will be injected immediately before spinal anesthesia for group B patients. The amount of injectable atropine 0.01 mg/kg per shift will be prescribed until the systolic blood pressure and HR reach the patient's baseline figure. It should be noted that the same drug brand will be used for all patients. During the operation, 500 cc of normal saline will be injected per hour of surgery.Patients' blood pressure and heart rate will be measured at baseline before spinal anesthesia and drug injection, then every 1 minute to 10 minutes, and then every 5 minutes to 45 minutes after drug injection. If the patient's blood pressure drops by more than 20% compared to the baseline value, in the treatment groups, in addition to receiving medication, normal saline will be injected for free
Category
Prevention
3
Description
Control group: Distilled water will be used in the control group, and in case of any hemodynamic disorder, routine treatment or scientific standard treatment will be started for the patient so that the patient will not be harmed during the research process. During the operation, 500 cc of normal saline will be injected per hour of surgery. became. Patients' blood pressure and heart rate will be measured at baseline before spinal anesthesia and drug injection, then every 1 minute to 10 minutes, and then every 5 minutes to 45 minutes after drug injection.In the control group, if the patient's blood pressure decreased by more than 20% compared to the baseline, she will receive medicine according to the routine treatment of the hospital.