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Completed

NCT Number: NCT06158048

ED90 of Norepinephrine and Phenylephrine Infusions Under Intensive Treatment

The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment during cesarean section

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

About this study

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment during cesarean section

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-45 years
  • Primipara or multipara
  • Singleton pregnancy ≥37 weeks
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for cesarean section under spinal anesthesia

Exclusion criteria

  • Body height < 150 cm
  • Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Treatment and study plan

norepinephrine

Drug

An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Other names: Vasopressor

Phenylephrine

Drug

An initial infusion dose of prophylactic phenylephrine (0.5 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.1 ug/kg/min of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.

Other names: Vasopressor

Primary outcomes

  1. ED50 and ED90

    Time frame: 1-15 minutes after spinal anesthesia

    The doses of prophylactic norepinephrine and phenylephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients

Secondary outcomes

  1. The incidence of post-spinal anesthesia hypotension

    Time frame: 1-15 minutes after spinal anesthesia

    Systolic blood pressure (SBP) < 80% of the baseline

Other outcomes

  1. The incidence of severe post-spinal anesthesia hypotension.

    Time frame: 1-15 minutes after spinal anesthesia

    Systolic blood pressure (SBP) < 60% of the baseline.

  2. The incidence of bradycardia.

    Time frame: 1-15 minutes after spinal anesthesia

    Heart rate < 60 beats/min.

  3. The incidence of nausea and vomiting.

    Time frame: 1-15 minutes after spinal anesthesia

    Presence of nausea and vomiting in patients after spinal anesthesia

  4. The incidence of hypertension.

    Time frame: 1-15 minutes after spinal anesthesia

    Systolic blood pressure (SBP) >120% of the baseline.

  5. pH

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  6. Base excess

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  7. Partial pressure of oxygen (PO2)

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  8. APGAR score

    Time frame: 1 min after delivery

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)

  9. APGAR score

    Time frame: 5 min after delivery

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

ED90 of Norepinephrine and Phenylephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive Treatment During Cesarean Section

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2023
Registry last updated
May 25, 2025

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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