Norepinephrine ED90 Bolus After Spinal Anesthesia in Cesarean Section

NCT06574555 | Completed Phase 4 DMC

• 1 other identifier: 240816002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are aiming to determine what is the effective intravenous dose required of an initial bolus of norepinephrine prior to a maintenance infusion to prevent a 20% decrease in maternal blood pressure from baseline following the administration of spinal anesthesia for elective cesarean section in healthy parturients

Conditions

Hypotension; Hypertension; Nausea; Pain; Arrhythmia

Keywords

Hypotension; Hypertension; Nausea; Pain; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Hypotension

  The primary outcome will be the presence of arterial hypotension within 10 minutes of anesthesia administration. Post-spinal arterial hypotension will be defined as systolic BP decreasing to less than 80% of baseline.

  First 10 minutes after spinal anesthesia dose.

Secondary Outcomes (2)

• Maternal side effects

  First 10 minutes after spinal injection

• Fetal side effects

  Until completion of the surgical procedure

Study Arms (2)

Sequence A

EXPERIMENTAL

Patients will be randomly assigned to sequence A who receive the study drug, norepinephrine. The initial bolus doses of norepinephrine will be 0.15 µg/kg.

Drug: Norepinephrine

Sequence B

EXPERIMENTAL

Patients will be randomly assigned to sequence B who receive the study drug, norepinephrine. The initial bolus doses of norepinephrine will be 0.13 µg/kg.

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

The outcome of patient n in each sequence will determine the dose to be allocated patient n+1. Successive doses will be determined with the up-and-down k-in-row design method for ED90 determination: * Failure: the dose should be increased in one level (+0.02 µg/kg) after failure to respond (arterial hypotension); * Success: decrease in one level (-0.02 µg/kg) upon successful response (no arterial hypotension), but only after observing at least k-consecutive positive responses at the same dose (in this case, k=7); otherwise, remain at the same dose. This will be done until each sequence completes n=30.

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Full-term singleton pregnant patients
• ASA II or III
• Scheduled for elective cesarean section
• Age between 18 and 40 years.

You may not qualify if:

• Hypertensive disorders of pregnancy
• Cardiovascular disease
• Baseline systolic BP \<100 mmHg
• Height less than 145 cm or greater than 180 cm
• Weight less than 40 kg or greater than 100 kg
• Need for uterine exteriorization during surgery
• Coagulation disorders.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clinico, Pontificia Universidad Catolica de Chile

Santiago, RM, 8330024, Chile

Location

Related Publications (7)

• Ngan Kee WD, Lee SW, Ng FF, Tan PE, Khaw KS. Randomized double-blinded comparison of norepinephrine and phenylephrine for maintenance of blood pressure during spinal anesthesia for cesarean delivery. Anesthesiology. 2015 Apr;122(4):736-45. doi: 10.1097/ALN.0000000000000601.

  PMID: 25635593 RESULT

• Ngan Kee WD, Khaw KS, Ng FF, Lee BB. Prophylactic phenylephrine infusion for preventing hypotension during spinal anesthesia for cesarean delivery. Anesth Analg. 2004 Mar;98(3):815-21, table of contents. doi: 10.1213/01.ane.0000099782.78002.30.

  PMID: 14980943 RESULT

• Ngan Kee WD, Lee SWY, Ng FF, Khaw KS. Prophylactic Norepinephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery. Anesth Analg. 2018 Jun;126(6):1989-1994. doi: 10.1213/ANE.0000000000002243.

  PMID: 28678073 RESULT

• Ngan Kee WD, Khaw KS, Ng FF. Prevention of hypotension during spinal anesthesia for cesarean delivery: an effective technique using combination phenylephrine infusion and crystalloid cohydration. Anesthesiology. 2005 Oct;103(4):744-50. doi: 10.1097/00000542-200510000-00012.

  PMID: 16192766 RESULT

• Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.

  PMID: 30335625 RESULT

• Chen Y, Guo L, Qin R, Xi N, Wang S, Ma Y, Ni X. Dose-Response Study of Norepinephrine Infusion for Maternal Hypotension in Preeclamptic Patients Undergoing Cesarean Delivery Under Spinal Anesthesia. Clin Pharmacokinet. 2024 Jun;63(6):847-856. doi: 10.1007/s40262-024-01381-4. Epub 2024 Jun 13.

  PMID: 38869701 RESULT

• Belin O, Casteres C, Alouini S, Le Pape M, Dupont A, Boulain T. Manually Controlled, Continuous Infusion of Phenylephrine or Norepinephrine for Maintenance of Blood Pressure and Cardiac Output During Spinal Anesthesia for Cesarean Delivery: A Double-Blinded Randomized Study. Anesth Analg. 2023 Mar 1;136(3):540-550. doi: 10.1213/ANE.0000000000006244. Epub 2022 Oct 24.

  PMID: 36279409 RESULT

MeSH Terms

Conditions

Hypotension; Hypertension; Nausea; Pain; Arrhythmias, Cardiac

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Heart Diseases; Pathologic Processes

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

• Ivonne Vargas Celis, MD

  Presidente, Comité Ético Científico Salud de la Universidad Católica

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: April 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 2, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: november 2025-novembre 2027
• Access Criteria: Researchers after reaonable request, looking at similar outcomes as ours.

Locations

CL (1)