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Norepinephrine on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia

Effect of Prophylactic Intravenous Norepinephrine Infusion on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia for Caesarean Section

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06498115
Enrollment
100
Registered
2024-07-12
Start date
2024-07-31
Completion date
2024-12-31
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Hypotension

Keywords

norepinephrine, maternal hypotension

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).

Interventions

DRUGNorepinephrine

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.

Sponsors

The Third People's Hospital of Bengbu
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Intraoperative adverse reactionsPerioperative periodDizziness, chest tightness, nausea, vomiting, bradycardia, secondary hypertension and other adverse reactions
Number of remedial drugsPerioperative periodIncludes incidence of remedial use of atropine, incidence of remedial use of norepinephrine.
Neonatal Apgar scoreImmediately After delivery of the foetusNeonatal 1-min and 5-min Apgar scores

Countries

China

Contacts

Primary ContactChengfei Xu
bbxcfpain@163.com+8615255098850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026