Norepinephrine on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorThe Third People's Hospital of Bengbu

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Norepinephrine BolusExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Intraoperative adverse reactions

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

Time frame
Perioperative period
2

Number of remedial drugs

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

Time frame
Perioperative period
3

Neonatal Apgar score

Neonatal 1-min and 5-min Apgar scores

Time frame
Immediately After delivery of the foetus

Other outcomes

Sponsors and contacts

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