Effect of Prophylactic Intravenous Norepinephrine Infusion on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia for Caesarean Section
Overview
- Phase
- Phase 4
- Intervention
- Norepinephrine
- Conditions
- Maternal Hypotension
- Sponsor
- The Third People's Hospital of Bengbu
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Intravenous norepinephrine to maintain maternal systolic blood pressure 80% above baseline before fetal delivery.
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
Investigators
Chengfei Xu
doctor-in-charge
The Third People's Hospital of Bengbu
Eligibility Criteria
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.
Arms & Interventions
Norepinephrine Bolus
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.
Intervention: Norepinephrine
Outcomes
Primary Outcomes
Intravenous norepinephrine to maintain maternal systolic blood pressure 80% above baseline before fetal delivery.
Time Frame: 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 Outcomes
- Neonatal Apgar score(Immediately After delivery of the foetus)
- Intraoperative adverse reactions(Perioperative period)
- Number of remedial drugs(Perioperative period)