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NCT Number: NCT06498115

Norepinephrine on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia

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).

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Key information

Conditions

Maternal Hypotension

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Third People's Hospital of Bengbu

Bengbu, Anhui, 233000, China

Location status: Recruiting

Location contact

Chengfei Xu

CONTACT

[email protected]

+8615255098850

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Intraoperative adverse reactions

    Time frame: Perioperative period

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

  2. Number of remedial drugs

    Time frame: Perioperative period

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

  3. Neonatal Apgar score

    Time frame: Immediately After delivery of the foetus

    Neonatal 1-min and 5-min Apgar scores

Study contacts

Contact information is provided by the study sponsor or research team.

Chengfei Xu

CONTACT

[email protected]

+8615255098850

Sponsors and collaborators

Lead sponsor

The Third People's Hospital of Bengbu

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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