- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05881915
Epinephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery
Epinephrine Versus Phenylephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery: a Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Upon arrival to the operating room, routine monitoring will be applied (electrocardiography, pulse oximetry, and a non-invasive blood pressure monitor). Two 18G-cannula will be inserted, and 10 mg metoclopramide and 50 mg ranitidine will be delivered. Co-load infusion of lactated Ringer's solution will be infused at a rate of 15 mL/Kg over 10 minutes, and 10 mg hyperbaric bupivacaine in addition to 20 mcg fentanyl will be injected in the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.
After subarachnoid block, mothers will be placed in a supine position with left-lateral tilt and will receive the vasopressor infusion according to the allocated study group:
- Phenylephrine group (n=113): will receive phenylephrine infusion at rate of 0.4 mcg/Kg/min. (10 mg /1 mL) will be diluted to reach a final concentration of 10 mcg/mL(5).
- Epinephrine group (n=113): will receive epinephrine infusion dose of 0.03 mcg/Kg/min. epinephrine (1mg/ 1mL ampoule) will be diluted to reach a final concentration of 10 mcg/ml.
The prophylactic vasopressor infusion will be maintained until 5 minutes after delivery of the fetus
Hemodynamic management in both groups will be as follow:
Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by either ephedrine 9 mg bolus (if the heart rate was below 75 bpm) or phenylephrine 50 mg bolus (if the heart rate was above 75 bpm).
Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) will be managed by administration of either ephedrine 15 mg (if the heart rate was below 75 bpm) or phenylephrine 100 mg bolus (if the heart rate was above 75 bpm).
Reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading) will be managed by stoppage of the infusion till the next systolic blood pressure reading. The infusion will be then re-started at a reduced rate (50% of the initial dose) when systolic blood pressure will have decreased to be within 20% of the baseline reading.
Intraoperative bradycardia (defined as a heart rate less than 55 bpm) will be managed by stoppage of the vasopressor infusion if not associated with hypotension. The infusion will be then re-started at a reduced rate (50%) when the heart rate is more than 55 bpm. IV atropine bolus (0.5 mg) will be administered if bradycardia persisted despite stoppage of the infusion. If accompanied with hypotension, bradycardia will be managed by IV bolus of ephedrine 9 mg.
Fluid administration will be continued up to a maximum of 1.5 liters. After delivery, an oxytocin bolus (0.5 IU) will be delivered over five seconds, followed by infusion at a rate of 2.5 IU/hour.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 115711
- Yasmin Ibrahim
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- full-term singleton pregnant women, admitted for elective cesarean delivery
- aged between 18 and 40 years
Exclusion Criteria:
- Patients with uncontrolled cardiac morbidities, hypertensive disorders of pregnancy
- Peripartum bleeding
- coagulation disorders
- Baseline systolic blood pressure (SBP) < 100 mmHg
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: epinephrine
|
epinephrine infusion dose of 0.03 mcg/Kg/min.
epinephrine (1mg/ 1mL ampoule) will be diluted to reach a final concentration of 10 mcg/ml.
|
Active Comparator: phenylephrine
|
phenylephrine infusion at rate of 0.4 mcg/Kg/min.
(10 mg /1 mL) will be diluted to reach a final concentration of 10 mcg/mL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of post spinal hypotension
Time Frame: from spinal anesthesia till delivery of fetus (about 45-60 mins)
|
systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus
|
from spinal anesthesia till delivery of fetus (about 45-60 mins)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence post spinal reactive hypertension
Time Frame: from spinal anesthesia till delivery of fetus (about 45-60 mins)
|
defined as systolic blood pressure ≥120% from the baseline reading
|
from spinal anesthesia till delivery of fetus (about 45-60 mins)
|
fetal outcome
Time Frame: at birth
|
arterial blood gas
|
at birth
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bradycardia
Time Frame: from spinal anesthesia till delivery of fetus (about 45-60 mins)
|
heart rate less than 55 bpm
|
from spinal anesthesia till delivery of fetus (about 45-60 mins)
|
fetal outcome
Time Frame: at 1 min , and at 5 min
|
APGAR score (Appearance - Pulse - Grimace - Activity -Respiration ) normal 7-10
|
at 1 min , and at 5 min
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypotension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Epinephrine
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- MD-245-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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