Epinephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery
Primary Purpose
Hypotension During Surgery
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Phenylephrine
Epinephrine
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension During Surgery
Eligibility Criteria
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
Sites / Locations
- Yasmin IbrahimRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
phenylephrine
epinephrine
Arm Description
Outcomes
Primary Outcome Measures
incidence of post spinal hypotension
systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus
Secondary Outcome Measures
incidence post spinal reactive hypertension
defined as systolic blood pressure ≥120% from the baseline reading
fetal outcome
arterial blood gas
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05881915
Brief Title
Epinephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery
Official Title
Epinephrine Versus Phenylephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Subarachnoid block is the common route of anesthesia for cesarean delivery. Maternal hypotension after subarachnoid block is very common despite the vigorous methods for its prevention. Maternal hypotension is sometimes deleterious to the mother and the fetus; thus, it is highly recommended to use prophylactic vasopressors directly after the block and before the blood pressure drops. The aim of this work is to compare the maternal and neonatal effects of epinephrine and phenylephrine when used as prophylactic infusion after subarachnoid block for cesarean delivery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension During Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
phenylephrine
Arm Type
Active Comparator
Arm Title
epinephrine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidence of post spinal hypotension
Description
systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus
Time Frame
from spinal anesthesia till delivery of fetus (about 45-60 mins)
Secondary Outcome Measure Information:
Title
incidence post spinal reactive hypertension
Description
defined as systolic blood pressure ≥120% from the baseline reading
Time Frame
from spinal anesthesia till delivery of fetus (about 45-60 mins)
Title
fetal outcome
Description
arterial blood gas
Time Frame
at birth
Other Pre-specified Outcome Measures:
Title
fetal outcome
Description
APGAR score (Appearance - Pulse - Grimace - Activity -Respiration ) normal 7-10
Time Frame
at 1 min , and at 5 min
Title
bradycardia
Description
heart rate less than 55 bpm
Time Frame
from spinal anesthesia till delivery of fetus (about 45-60 mins)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yasmin Ibrahim
City
Cairo
ZIP/Postal Code
115711
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yasmin ibrahim
Phone
01006719987
Email
yalnaby@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Epinephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery
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