NCT06102382

Brief Summary

To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
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

October 21, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

October 21, 2023

Last Update Submit

August 24, 2025

Conditions

Cesarean SectionHypotensionNorepinephrine

Keywords

NorepinephrineSpinal anesthesiaHypotensionCesarean section

Outcome Measures

Primary Outcomes (1)

  • The frequency of post-spinal hypotension

    During the first hour after the subarachnoid block

Secondary Outcomes (4)

  • Arterial blood pressure (Systolic, diastolic, and mean)

    During the first hour after the subarachnoid block

  • Heart rate

    During the first hour after the subarachnoid block

  • Doses of atropine and ephedrine

    Intraoperative

  • Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score

    1, 5, and 10 minutes after delivery

Study Arms (2)

Norepinephrine (0.1)

EXPERIMENTAL

An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.

Drug: Norepinephrine (0.1)

Norepinephrine (0.075)

ACTIVE COMPARATOR

An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.

Drug: Norepinephrine (0.075)

Interventions

Norepinephrine (0.1)DRUG

An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.

Norepinephrine (0.1)
Norepinephrine (0.075)DRUG

An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.

Norepinephrine (0.075)

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women scheduled for cesarean section under spinal anesthesia
  • Gestational age of at least 37 weeks

You may not qualify if:

  • Patient refusal
  • Contraindications of spinal anesthesia
  • Allergy to the study drug
  • Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2.
  • patients with cardiac morbidities
  • Hypertensive disorders of pregnancy.
  • Prepartum hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Woman Health Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Zakaria A. Zakaria

CONTACT

+201150637566za6841924@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2023

First Posted

October 26, 2023

Study Start

September 1, 2024

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations

EG(1)