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Completed

NCT Number: NCT05881915

Epinephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yasmin Ibrahim

Cairo, 115711, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine

Drug

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

Epinephrine

Drug

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. fetal outcome

    Time frame: at birth

    arterial blood gas

Other outcomes

  1. fetal outcome

    Time frame: at 1 min , and at 5 min

    APGAR score (Appearance - Pulse - Grimace - Activity -Respiration ) normal 7-10

  2. bradycardia

    Time frame: from spinal anesthesia till delivery of fetus (about 45-60 mins)

    heart rate less than 55 bpm

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Epinephrine Versus Phenylephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery: a Randomized Controlled Trial.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 31, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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