Prophylactic Norepinephrine Infusion Combined With Colloid Coloading for Postspinal Anesthesia Hypotension

Overview

The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.

Full Title of Study: “Prophylactic Norepinephrine Infusion Combined With 6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled, Dose-finding Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 31, 2022

Detailed Description

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. But the ideal infusion dose of norepinephrine with colloid coload is still unknown. The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.

Interventions

  • Drug: Normal saline
    • Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.
  • Drug: Norepinephrine (0.025 μg/kg/min)
    • Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
  • Drug: Norepinephrine (0.05 μg/kg/min)
    • Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
  • Drug: Norepinephrine (0.075 μg/kg/min)
    • Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
  • Drug: Norepinephrine (0.1 μg/kg/min)
    • Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.

Arms, Groups and Cohorts

  • Placebo Comparator: Control group
    • Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.
  • Experimental: 0.025 μg/kg/min group
    • Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.025 μg/kg/min) by IV infusion.
  • Experimental: 0.05 μg/kg/min group
    • Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.05 μg/kg/min) by IV infusion.
  • Experimental: 0.075 μg/kg/min group
    • Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.075 μg/kg/min) by IV infusion.
  • Experimental: 0.1μg/kg/min group
    • Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.1μg/kg/min) by IV infusion.

Clinical Trial Outcome Measures

Primary Measures

  • The incidence of post-spinal anesthesia hypotension
    • Time Frame: 1-15 minutes after spinal anesthesia
    • Systolic blood pressure (SBP) < 80% of the baseline

Secondary Measures

  • Overall stability of systolic blood pressure control versus baseline
    • Time Frame: 1-15 minutes after spinal anesthesia
    • Evaluated by performance error (PE).
  • The incidence of severe post-spinal anesthesia hypotension.
    • Time Frame: 1-15 minutes after spinal anesthesia
    • Systolic blood pressure (SBP) < 60% of the baseline.
  • The incidence of nausea and vomiting.
    • Time Frame: 1-15 minutes after spinal anesthesia
    • Presence of nausea and vomiting in patients after spinal anesthesia
  • The incidence of bradycardia.
    • Time Frame: 1-15 minutes after spinal anesthesia
    • Heart rate < 55 beats/min.
  • The incidence of hypertension.
    • Time Frame: 1-15 minutes after spinal anesthesia
    • Systolic blood pressure (SBP) >120% of the baseline.
  • pH
    • Time Frame: Immediately after delivery
    • From umbilical arterial blood gases.
  • Partial pressure of oxygen
    • Time Frame: Immediately after delivery
    • From umbilical arterial blood gases.
  • Base excess
    • Time Frame: Immediately after delivery
    • From umbilical arterial blood gases.
  • APGAR score
    • Time Frame: 1min after delivery
    • A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
  • APGAR score
    • Time Frame: 5 min after delivery
    • A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

Participating in This Clinical Trial

Criteria: 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 – Coagulation or renal function disorders – Known allergy to hydroxyethyl starch – Fetal distress, or known fetal developmental anomaly

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • General Hospital of Ningxia Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xinli Ni, Dr., Study Chair, General Hospital of Ningxia Medical University
  • Overall Contact(s)
    • Xinli Ni, Dr., 86-951-674-3252, xinlini6@nyfy.com.cn

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