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NCT Number: NCT06508359

Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension.

This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing 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

Spinal anesthesia-induced hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of spinal anesthesia-induced 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 spinal anesthesia-induced hypotension. The prophylactic vasopressor strategy is more effective in enhancing hemodynamic stability and reducing adverse events such as nausea and vomiting during cesarean section, compared to rescue strategy. However, it does not demonstrate significant advantages in neonatal outcomes such as umbilical artery pH and Apgar score. The impact of various vasopressor application patterns on neonatal outcomes after cesarean section lacks further supporting evidence. Therefore, this study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section through a multicenter, single-blind, 2*2 crossover and cluster randomized trial.

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 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 ≥140 mmHg
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Treatment and study plan

norepinephrine

Drug

Prophylactic or rescue norepinephrine for spinal anesthesia-induced hypotension

Other names: Vasopressor

Phenylephrine

Drug

Prophylactic or rescue phenylephrine for spinal anesthesia-induced hypotension

Other names: Vasopressor

Primary outcomes

  1. pH

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  2. Base excess (BE)

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

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

  2. The incidence of severe post-spinal anesthesia hypotension

    Time frame: 1-15 minutes after spinal anesthesia

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

  3. The incidence of bradycardia

    Time frame: 1-15 minutes after spinal anesthesia

    Heart rate < 60 beats/min

  4. The incidence of nausea and vomiting

    Time frame: 1-15 minutes after spinal anesthesia

    Presence of nausea and vomiting in patients after spinal anesthesia

  5. The incidence of hypertension

    Time frame: 1-15 minutes after spinal anesthesia

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

  6. Partial pressure of oxygen (PO2)

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  7. APGAR score

    Time frame: 1 min after delivery

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

  8. APGAR score

    Time frame: 5 min after delivery

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

Prophylactic vs Rescue Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes During Cesarean Section: A Multicenter, Single-blind, Crossover, Factorial Cluster Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2024
Registry last updated
Apr 28, 2026

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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