Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery

NCT ID: NCT05279703

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2022-08-31

Brief Summary

Maternal hypotension after spinal block is a common complication after subarachnoid block in this population. The incidence of maternal hypotension is nearly 60% when prophylactic vasopressors are not used. Therefore, it is highly recommended to use vasopressors, preferably as continuous infusion, for prophylaxis rather than delaying their use until hypotension occurs.

Phenylephrine (PE) is the recommended drug for prophylaxis against hypotension during cesarean delivery; however, the use of PE is commonly associated with decreased heart rate and probably cardiac output because PE is a pure alpha adrenoreceptor agonist. Introduction of NE in obstetric practice had shown favorable maternal and neonatal outcomes and was associated with higher heart rate and cardiac output compared to PE. However, there is still some mothers who develop bradycardia and diminished cardiac output with the use of NE. The most desired scenario during hemodynamic management of mothers during cesarean delivery would achieve the least possible incidences of maternal hypotension, bradycardia and reactive hypertension. Therefore, it is warranted to reach a vasopressor regimen with the most stable hemodynamic profile.

In the last year, epinephrine was reported for the first time in obstetric practice with acceptable safety on the mother and the fetus. However, there is still lack of data about the most appropriate dose for infusion during cesarean delivery. This study aims to compare three prophylactic infusion rates for epinephrine during cesarean delivery.

Detailed Description

Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.

Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.

After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and the vasopressor infusion will be started.

• 0.01 mcg group
• 0.02 mcg group
• 0.03 mcg group The vasopressor infusion will be through the same line as the fluid a three-way stopcock. The vasopressor infusion will be stopped if heart rate became ≥130% of baseline or systolic blood pressure ≥120% of baseline, otherwise the infusion will be stopped 5 minutes after delivery of the baby.

Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.

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 administration of 9 mg of ephedrine Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration IV ephedrine 15 mg.

Reactive hypertension (defined as systolic blood pressure ≥120% of 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 the half of the initial rate, when systolic blood pressure decreases to be within 20% of the baseline reading.

Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.

Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (0.5 IU) will be delivered over five seconds after delivery the infused at a rate of 2.5 IU/hour.

Conditions

Postspinal Hypotension; Cesarean Delivery; Epinephrine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

0.03 mcg group

epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby

Group Type: ACTIVE_COMPARATOR

Epinephrine 0.03

Intervention Type: DRUG

epinephrine infusion rate of 0.03 mcg/kg/min

0.02 mcg group

epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby

Group Type: ACTIVE_COMPARATOR

Epinephrin 0.02

Intervention Type: DRUG

epinephrine infusion rate of 0.02 mcg/kg/min

0.01 mcg group

epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby

Group Type: ACTIVE_COMPARATOR

Epinephrin 0.01

Intervention Type: DRUG

epinephrine infusion rate of 0.01 mcg/kg/min

Interventions

Epinephrine 0.03

epinephrine infusion rate of 0.03 mcg/kg/min

Intervention Type: DRUG

Epinephrin 0.02

epinephrine infusion rate of 0.02 mcg/kg/min

Intervention Type: DRUG

Epinephrin 0.01

epinephrine infusion rate of 0.01 mcg/kg/min

Intervention Type: DRUG

Other Intervention Names

adrenaline; adrenaline; adrenaline

Eligibility Criteria

Inclusion Criteria

• full-term singleton pregnant women
• American society of anesthesiologist-physical status I or II,
• scheduled for elective cesarean delivery

Exclusion Criteria

• Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
• hypertensive disorders of pregnancy,
• peripartum bleeding,
• coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or
• any contraindication to regional anesthesia,
• and baseline systolic blood pressure (SBP) < 100 mmHg

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maha Mostafa Ahmad, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alaini Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

ahmed hasanin

Role: CONTACT

ahmedmohamedhasanin@gmail.com

01095076954

Facility Contacts

Anesthesia, Pain Management and Surgical ICU Department

Role: primary

Anesthesia.kasralainy@gmail.com

00201222224057

References

Hasanin AM, Abou Amer A, Hassabelnaby YS, Mostafa M, Abdelnasser A, Amin SM, Elsherbiny M, Refaat S. The use of epinephrine infusion for the prevention of spinal hypotension during Caesarean delivery: A randomized controlled dose-finding trial. Anaesth Crit Care Pain Med. 2023 Jun;42(3):101204. doi: 10.1016/j.accpm.2023.101204. Epub 2023 Feb 28.

Reference Type: DERIVED

PMID: 36858257 (View on PubMed)

Other Identifiers

MD-399-2021

Identifier Type: -

Identifier Source: org_study_id