Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery

NCT05279703 | Unknown Phase 4

• 1 other identifier: MD-399-2021
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Postspinal Hypotension; Cesarean Delivery; Epinephrine

Outcome Measures

Primary Outcomes (1)

• incidence of postspinal hypotension

  systolic blood pressure ≤80% of the baseline reading

  1 minute after subarachnoid injection till 5 minutes after baby delivery

Secondary Outcomes (12)

• incidence of tachycardia

  1 minute after subarachnoid injection till 5 minutes after baby delivery

• incidence of hypertension

  1 minute after subarachnoid injection till 5 minutes after baby delivery

• incidence of severe hypotension

  1 minute after subarachnoid injection till 5 minutes after baby delivery

• mean heart rate

  1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery

• mean systolic blood pressure

  1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery

Study Arms (3)

0.03 mcg group

ACTIVE COMPARATOR

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

Drug: Epinephrine 0.03

0.02 mcg group

ACTIVE COMPARATOR

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

Drug: Epinephrin 0.02

0.01 mcg group

ACTIVE COMPARATOR

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

Drug: Epinephrin 0.01

Interventions

Epinephrine 0.03 DRUG

epinephrine infusion rate of 0.03 mcg/kg/min

Also known as: adrenaline

0.03 mcg group

Epinephrin 0.02 DRUG

epinephrine infusion rate of 0.02 mcg/kg/min

Also known as: adrenaline

0.02 mcg group

Epinephrin 0.01 DRUG

epinephrine infusion rate of 0.01 mcg/kg/min

Also known as: adrenaline

0.01 mcg group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 36858257 DERIVED

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

ahmed hasanin

CONTACT

01095076954; ahmedmohamedhasanin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 15, 2022
• Study Start: March 21, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)