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CompletedNCT05881915Updated Feb 28, 2024

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

An interventional study of Phenylephrine and Epinephrine in Hypotension During Surgery, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypotension During Surgery

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03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 196 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • full-term singleton pregnant women, admitted for elective cesarean delivery
  • aged between 18 and 40 years

Exclusion criteria

Exclusion Criteria:

  • Patients with uncontrolled cardiac morbidities, hypertensive disorders of pregnancy
  • Peripartum bleeding
  • coagulation disorders
  • Baseline systolic blood pressure (SBP) \< 100 mmHg
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
196 participants (actual)

Study arms

  • Active comparator
    phenylephrine

    Drug: Phenylephrine

  • Active comparator
    epinephrine

    Drug: Epinephrine

Interventions

  • DrugPhenylephrine

    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

  • DrugEpinephrine

    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.

06

What researchers measure

Primary outcomes

  1. incidence of post spinal hypotension

    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 outcomes

  1. incidence post spinal reactive hypertension

    defined as systolic blood pressure ≥120% from the baseline reading

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

  2. fetal outcome

    arterial blood gas

    Time frame: at birth

Other outcomes

  1. fetal outcome

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

    Time frame: at 1 min , and at 5 min

  2. bradycardia

    heart rate less than 55 bpm

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

07

Study locations

1 site
  • Yasmin Ibrahim
    Cairo, 115711, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05881915
Lead sponsor
Cairo University
Responsible party
Yasmin Hassab elnaby (assistant professor, Cairo University) — Principal investigator
First posted
May 31, 2023
Start date
Jun 1, 2023
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023
Last update
Feb 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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