Norepinephrine in Caesarian Section

NCT05264870 | Terminated Phase 4

• 1 other identifier: 002105
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Postspinal hypotension is a frequent maternal complication in caesarian delivery under neuraxial anesthesia which is most commonly treated with the administration of phenylephrine infusion. In this trial, postspinal hypotension will be treated with norepinephrine. The main objective is to examine the pharmacodynamic and biochemical effect of norepinephrine both on mother and newborn.

Conditions

Cesarean Section Complications; Hemodynamic Instability; Foetal Stress

Outcome Measures

Primary Outcomes (2)

• dose norepinephrine used in group A

  dose in microgram of norepinephrine used for treatment of hypotension in both arms

  from administration of spinal anesthesia until delivery of the newborn

• dose norepinephrine used in group B

  dose in microgram of norepinephrine used for treatment of hypotension in both arms

  from administration of spinal anesthesia until delivery of the newborn

Secondary Outcomes (1)

• biochemical effect of norepinephrine on the newborn

  bloodsample taken from umbilical cord at birth

Study Arms (2)

Group A

ACTIVE COMPARATOR

combined spinal epidural anesthesia (CSE) with 7,5mg hyperbaric Marcaine and 2,5mcg Sufentanil

Drug: Norepinephrine

Group B

ACTIVE COMPARATOR

combined spinal epidural anesthesia (CSE) anesthesia with 10mg hyperbaric Marcaine and 2,5mcg Sufentanil

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

treatment of postspinal hypotension

Group A

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists classification (ASA)1 and 2 patients
• non-laboring and singleton pregnancy

You may not qualify if:

• patients with cardiovascular comorbidities
• any kind of cardiac and peripheral vascular disease or diabetes
• history of coagulopathy
• contra-indication to spinal anesthesia
• allergic condition to vasopressors or local anesthetics
• total body weight under 50kg or above 100kg
• length under 150cm and over 180cm Body Mass Index (BM)I ≥ 32

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, 2650, Belgium

Location

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hanne Ryckebosch, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both the patient and the observant/study physician are fully blinded. Randomization, preparation of study medication and administration of CSE anesthesia is performed by a protocol trained anesthesiologist. He or she is further excluded to any other study related intervention. A second protocol trained anesthetist comes in and will adapt the norepinephrine infusion according to the needs of the patient. He will do routine care observations and interventions until end of surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Norepinephrine infusion is given for treatment of postspinal hypotension in treatment group A and B

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: June 9, 2022
• Primary Completion: March 2, 2023
• Study Completion: August 27, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

BE (1)