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Completed

NCT Number: NCT04272567

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

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Key information

Age range

18 year–40 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. Vasopressors 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. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-40 years
  • Primipara or multipara
  • Singleton pregnancy ≥37 weeks
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for elective 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 ≥ 160mmHg
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Treatment and study plan

norepinephrine

Drug

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.

Other names: Vasopressors

normal saline

Drug

Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion

Other names: NS

Primary 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

Secondary outcomes

  1. Overall stability of systolic blood pressure control versus baseline

    Time frame: 1-15 minutes after spinal anesthesia.

    Evaluated by performance error (PE).

  2. Overall stability of heart rate control versus baseline

    Time frame: 1-15 minutes after spinal anesthesia.

    Evaluated by performance error (PE).

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

    Time frame: 1-15 minutes after spinal anesthesia.

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

  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 bradycardia.

    Time frame: 1-15 minutes after spinal anesthesia.

    Heart rate < 55 beats/min.

  6. The incidence of hypertension.

    Time frame: 1-15 minutes after spinal anesthesia.

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

  7. pH

    Time frame: Immediately after delivery.

    From umbilical arterial blood gases.

  8. Partial pressure of oxygen

    Time frame: Immediately after delivery.

    From umbilical arterial blood gases.

  9. Base excess

    Time frame: Immediately after delivery.

    From umbilical arterial blood gases.

  10. APGAR score

    Time frame: 1min after delivery

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

  11. APGAR score

    Time frame: 5min 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

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2020
Registry last updated
Aug 4, 2020

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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