Norepinephrine on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia

NCT06498115 | Recruiting Phase 4

• 1 other identifier: 2024-k21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Norepinephrine has emerged as a potential alternative for stabilizing blood pressure during spinal anesthesia for cesarean section, purportedly maintaining maternal heart rate and cardiac output more effectively than phenylephrine. However, its application as an intravenous bolus for treating hypotension remains underexplored. Consequently, this current investigation aimed to determine the ED50 and ED95 of norepinephrine for managing maternal hypotension during cesarean section. A prospective trial enrolled 100 patients undergoing elective delivery under spinal anesthesia, with norepinephrine dosage determined using the upper and lower sequential distribution method (UDM).

Conditions

Maternal Hypotension

Keywords

norepinephrine; maternal hypotension

Outcome Measures

Primary Outcomes (1)

• Intravenous norepinephrine to maintain maternal systolic blood pressure 80% above baseline before fetal delivery.

  Intravenous norepinephrine pumped to maintain maternal systolic blood pressure 80% above its basal value prior to delivery of the foetus

  From the initiation of anesthesia to the delivery of the fetus.

Secondary Outcomes (3)

• Intraoperative adverse reactions

  Perioperative period

• Number of remedial drugs

  Perioperative period

• Neonatal Apgar score

  Immediately After delivery of the foetus

Study Arms (1)

Norepinephrine Bolus

EXPERIMENTAL

Participants in this arm will receive norepinephrine as a bolus dose to treat maternal hypotension during cesarean section under spinal anesthesia. The dosage will be determined using the upper and lower sequential distribution method (UDM). The aim is to investigate the effective dose (ED50 and ED95) of norepinephrine in maintaining maternal blood pressure stability and optimizing maternal outcomes during the procedure.

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

Participants in this arm will receive norepinephrine as a bolus dose to treat maternal hypotension during cesarean section under spinal anesthesia. The dosage will be determined using the upper and lower sequential distribution method (UDM). The aim is to investigate the effective dose (ED50 and ED95) of norepinephrine in maintaining maternal blood pressure stability and optimizing maternal outcomes during the procedure.

Norepinephrine Bolus

Eligibility Criteria

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

Sponsors & Collaborators

• The Third People's Hospital of Bengbu: lead

Study Sites (1)

The Third People's Hospital of Bengbu

Bengbu, Anhui, 233000, China

RECRUITING

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

• Liang Cheng

  The Third People's Hospital of Bengbu

  STUDY DIRECTOR

Central Study Contacts

Chengfei Xu

CONTACT

+8615255098850; bbxcfpain@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor-in-charge

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)