NCT06512402

Brief Summary

Epinephrine is a well-known vasoactive agent in medical practice. However, its use is obstetric population is still scanty. Few studies evaluated the use of epinephrine during Cesarean delivery and a recent randomized controlled dose-finding trial reached an acceptable incidence of hypotension (13%) with the use of 0.03 mcg/kg/min as prophylaxis. Being a newly introduced vasoactive agent in obstetric practice, it is essential to be adequately compared with other vasopressors using the optimum dosage and appropriate outcomes. There are no data, till date, comparing epinephrine versus norepinephrine infusion during Cesarean delivery using a composite outcome of hypotension, hypertension, and bradycardia. The aim of this study is to compare epinephrine versus norepinephrine infusion for prophylaxis against post-spinal hypotension during Caesarean delivery

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 16, 2024

Last Update Submit

July 16, 2024

Conditions

HypotensionSpinal BlockCesarean Section

Outcome Measures

Primary Outcomes (1)

  • incidence of post-spinal hemodynamic instability

    the occurrence of either, hypotension, hypertension, bradycardia, and/or tachycardia

    1 min after spinal anesthesia until 5 min after the delivery

Secondary Outcomes (4)

  • umbilical pH

    5 min after delivery

  • Apgar

    5 min after delivery

  • heart rate

    1 min after spinal anesthesia until 5 min after the delivery

  • systolic blood pressure

    1 min after spinal anesthesia until 5 min after the delivery

Study Arms (2)

Norepinephrine group

ACTIVE COMPARATOR

After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive norepinephrine infusion until 5 min after delivery

Drug: Norepinephrine

Epinephrine group

ACTIVE COMPARATOR

After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive epinephrine infusion until 5 min after delivery

Drug: Epinephrine

Interventions

NorepinephrineDRUG

patients will receive norepinephrine infusion at rate of 0.05 mcg/Kg/min

Norepinephrine group
EpinephrineDRUG

patients will receive epinephrine infusion dose of 0.03 mcg/Kg/min

Epinephrine group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • full-term singleton pregnant women, admitted 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,
  • baseline systolic blood pressure (SBP) \< 100 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

NorepinephrineEpinephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
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

July 16, 2024

First Posted

July 22, 2024

Study Start

August 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

July 22, 2024

Record last verified: 2024-07

Locations

EG(1)