Norepinephrine on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia

Phase 4RecruitingNCT06498115

The Third People's Hospital of Bengbu100 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Maternal Hypotension

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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.

Outcomes

Primary Outcomes

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

Time frame: From the initiation of anesthesia to the delivery of the fetus.

Secondary Outcomes

Intraoperative adverse reactions

Dizziness, chest tightness, nausea, vomiting, bradycardia, secondary hypertension and other adverse reactions

Time frame: Perioperative period

Number of remedial drugs

Includes incidence of remedial use of atropine, incidence of remedial use of norepinephrine.

Time frame: Perioperative period

Neonatal Apgar score

Neonatal 1-min and 5-min Apgar scores

Time frame: Immediately After delivery of the foetus