Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section

NCT05051150 | Terminated Phase 4

• 1 other identifier: N-31-2021
• Study Type: interventional
• Target: 18
• 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. In this study, we aim to compare three prophylactic infusion rates for epinephrine during cesarean delivery.

Conditions

Post-spinal Hypotension; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• the incidence of post-spinal hypotension

  systolic blood pressure less than 80% of baseline value

  1 minutes after spinal injection until 5-minutes after the baby delivery

Secondary Outcomes (6)

• the incidence of severe post-spinal hypotension

  1 minutes after spinal injection until 5-minutes after the baby delivery

• the incidence of reactive hypertension

  1 minutes after spinal injection until 5-minutes after the baby delivery

• total ephedrine dose

  1 minutes after spinal injection until 5-minutes after the baby delivery

• the incidence of tachycardia

  1 minutes after spinal injection until 5-minutes after the baby delivery

• the incidence of bradycardia

  1 minutes after spinal injection until 5-minutes after the baby delivery

Study Arms (3)

epinephrine 0.03 mcg

ACTIVE COMPARATOR

Drug: Epinephrin 0.03

epinephrine 0.05 mcg

ACTIVE COMPARATOR

Drug: Epinephrin 0.05

epinephrine 0.07 mcg

ACTIVE COMPARATOR

Drug: Epinephrin 0.07

Interventions

Epinephrin 0.03 DRUG

epinephrine infusion rate of 0.03 mcg/kg/min will start from subarachnoid injection of local anesthetic until 5-min after baby delivery

epinephrine 0.03 mcg

Epinephrin 0.05 DRUG

epinephrine infusion rate of 0.05 mcg/kg/min will start from subarachnoid injection of local anesthetic until 5-min after baby delivery

epinephrine 0.05 mcg

Epinephrin 0.07 DRUG

epinephrine infusion rate of 0.07 mcg/kg/min will start from subarachnoid injection of local anesthetic until 5-min after baby delivery

epinephrine 0.07 mcg

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 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)
• any contraindication to regional anesthesia,
• baseline systolic blood pressure (SBP) \< 100 mmHg will be excluded from the study

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

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: September 10, 2021
• First Posted: September 21, 2021
• Study Start: September 15, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-02

Locations

EG (1)