NCT07379710

Brief Summary

We hypothesize that the addition of ephedrine to norepinephrine infusion could decrease the incidence of post spinal hypotension(PSH) in parturient undergoing C.S under spinal anesthesia and minimize the changes in heart rate

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
8mo left

Started Jun 2026

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

January 23, 2026

Last Update Submit

April 27, 2026

Conditions

Incidence of Post-spinal Hypotension

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-spinal hypotension

    Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

Secondary Outcomes (6)

  • Incidence of bradycardia

    Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

  • Reactive hypertension

    Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

  • Systolic blood pressure

    Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

  • Heart rate

    Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

  • Rescue vasopressor consumption

    Just after spinal anaesthesia until delivery of the fetus

  • +1 more secondary outcomes

Study Arms (2)

Group(A)

ACTIVE COMPARATOR

Ephedrine 10 mg (2.5mg/ml) direct I.V will be given simultaneous with Norepinephrine infusion 0.08 mcg/kg/min

Drug: Ephedrine and Norepinephrine infusion

Group (B)

ACTIVE COMPARATOR

4 ml normal saline direct I.V will be given simultaneous with norepinephrine (to keep blinding) Infusion 0.08 mcg/kg/min only be infused

Drug: Norepinephrine infusion

Interventions

Ephedrine and Norepinephrine infusionDRUG

Ephedrine 10 mg (2.5mg/ml) direct I.V will be given simultaneous with Norepinephrine infusion 0.08 mcg/kg/min

Group(A)
Norepinephrine infusionDRUG

4 ml normal saline direct I.V will be given simultaneous with norepinephrine (to keep blinding) Infusion 0.08 mcg/kg/min only be infused

Group (B)

Eligibility Criteria

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

You may qualify if:

  • ASA physical status II
  • Age: 18 to 40 years
  • Undergoing Elective Lower Segment Cesarean Section under Spinal Anesthesia.

You may not qualify if:

  • Uncontrolled cardiac morbidities As reduction of ejection fraction\< 60%, History (within 3months) of myocardial infarction, cerebrovascular accident, transient ischemic attacks or coronary artery disease/stents
  • Poorly controlled Hypertensive disorders of pregnancy
  • Peripartum bleeding
  • Coagulation disorders
  • Baseline systolic blood pressure (SBP) \< 100 mmHg
  • Refusal of patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University, Cairo

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Ephedrine

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Study Officials

  • Mohamed A Ollaek, MD

    Faculty of Medicine, Cairo University, Cairo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed AMY AMY Ollaek, Assistant Professor

CONTACT

+20100 659 5598ollaekm@kasralainy.edu.eg

Islam Reda, Lecturer

CONTACT

+201003315095islam.reda@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)