Norepinephrine on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia

Phase 4

Recruiting

• Conditions: Maternal Hypotension
• Interventions: Drug: Norepinephrine

• Registration Number: NCT06498115
• Lead Sponsor: The Third People's Hospital of Bengbu

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted: 2024-07-06
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Inclusion criteria included women undergoing elective caesarean section undergoing combined lumbar and rigid anaesthesia, healthy singleton pregnancies at full term (more than 37 weeks gestation), American Society of Anaesthesiologists physical status I or II, body weight between 50-100 kg, height between 150-180 cm, and fasting for more than 8 hours.

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Exclusion Criteria

The exclusion criteria included individuals with hypertension, cardiovascular diseases, preeclampsia, arrhythmias, diabetes mellitus, spinal cord malformations, abnormal fetal conditions, and those who declined to participate in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Norepinephrine Bolus	Norepinephrine	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.

Primary Outcome Measures

Name	Time	Method
Intravenous norepinephrine to maintain maternal systolic blood pressure 80% above baseline before fetal delivery.	From the initiation of anesthesia to the delivery of the fetus.	Intravenous norepinephrine pumped to maintain maternal systolic blood pressure 80% above its basal value prior to delivery of the foetus

Secondary Outcome Measures

Name	Time	Method
Number of remedial drugs	Perioperative period	Includes incidence of remedial use of atropine, incidence of remedial use of norepinephrine.
Neonatal Apgar score	Immediately After delivery of the foetus	Neonatal 1-min and 5-min Apgar scores
Intraoperative adverse reactions	Perioperative period	Dizziness, chest tightness, nausea, vomiting, bradycardia, secondary hypertension and other adverse reactions

Trial Locations

Locations (1)

The Third People's Hospital of Bengbu; 🇨🇳 Bengbu, Anhui, China