Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

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

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

Study Overview

• Status: Completed
• Conditions: Adverse Effect
• Intervention / Treatment: Drug: Normal saline; Drug: Norepinephrine

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion	Drug: Normal saline; Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion; Other Names: NS
Experimental: 0.025 μg/kg/min group; Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min).	Drug: Norepinephrine; Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.; Other Names: Vasopressors
Experimental: 0.05 μg/kg/min group; Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min).	Drug: Norepinephrine; Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.; Other Names: Vasopressors
Experimental: 0.075 μg/kg/min group; Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min).	Drug: Norepinephrine; Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.; Other Names: Vasopressors
Experimental: 0.1 μg/kg/min group; Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).	Drug: Norepinephrine; Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.; Other Names: Vasopressors

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Hypotension; Cesarean section; Norepinephrine; Dose-finding
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: Yi Chen-2020-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No