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NCT Number: NCT05035888

Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean 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, 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. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, few studies had been indicated the ED50 (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine bolus and its potency compared to phenylephrine for postspinal anesthesia hypotension in patients undergoing caesarean section. The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean 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

Phenylephrine

Drug

An initial prophylactic bolus dose of phenylephrine (37.5μg) simultaneous with spinal anesthesia. If the patient did not respond adequately to the current dose (SBP decreased to < 80% of baseline), the dose was considered to have failed and the subsequent dose for the following patient was increased to the next higher dose level. The dose administered to subsequent patients varied by increments or decrements of 12.5 μg according to the responses of previous patients according to the up-down sequential allocation.

Other names: Vasopressors

norepinephrine

Drug

An initial prophylactic bolus dose of norepinephrine (3μg) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 μg according to the responses of previous patients according to the up-down sequential allocation.

Other names: Vasopressors

Primary outcomes

  1. The dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients

    Time frame: 1-15 minutes after spinal anesthesia

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

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. pH

    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. Base excess (BE)

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  9. APGAR score

    Time frame: 1 min after delivery

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

  10. 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 Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section: A Randomized Sequential Allocation Dose-finding Study.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
Jan 5, 2023

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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