Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index

Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study

The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (IVC-CI).

Study Overview

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

Detailed Description

Post-spinal hypotension is a frequent complication during spinal anesthesia for cesarean delivery. It affects nearly 50-60% of patients without appropriately treat. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal hypotension. Norepinephrine is new vasopressor that has been suggested as a potential alternative to phenylephrine and was recently introduced in obstetric anesthesia because of the minimal cardiac depressant effect. The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect on inferior vena cava collapsibility index (IVC-CI).

• Study Type: Interventional
• Enrollment (Actual): 195
• 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 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 18-45 years
• American Society of Anesthesiologists physical status classification I to II
• Scheduled for elective cesarean delivery under spinal anesthesia
• Full-term, singleton, pregnant women

Exclusion Criteria:

• Height of no more than 150 centimeters
• Body weight greater than 100 kg or BMI greater than 30
• Labor analgesia had been performed
• Contraindication of spinal or epidural anesthesia
• Eclampsia or chronic hypertension or baseline blood pressure ≥160mmHg
• Hemoglobin <7g/dl
• Fetal distress or known abnormal fetal development
• Severe vascular disease
• Diabetes mellitus or cardiovascular disease or nervous system disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal saline; Simultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion	Drug: normal saline; a bolus of normal saline was given followed by normal saline infusion; Other Names: NS
Experimental: Norepinephrine; Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion	Drug: Norepinephrine; a bolus of norepinephrine was given followed by norepinephrine infusion; Other Names: Vasopressors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of hypotension	SBP decreased to <80% of the baseline value	1 to 20 minutes after subarachnoid block
Inferior vena cava collapsibility index	CI = (dIVCmax - dIVCmin)/dIVCmax	5 to 20 minutes after subarachnoid block

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
The incidence of nausea and vomiting	Presence of nausea and vomiting in patients after subarachnoid block	1 to 20 minutes after subarachnoid block
The incidence of bradycardia	Heart rate less than 55 bpm	1 to 20 minutes after subarachnoid block
Incidence of hypertension	Systolic blood pressure at or above 120% of baseline	1 to 20 minutes after subarachnoid block
Arterial base excess of fetal vein blood	From umbilical vein blood gases	Immediately after delivery
Pressure of oxygen of fetal vein blood	From umbilical vein blood gases	Immediately after delivery
pH value of fetal vein blood	From umbilical vein blood gases	Immediately after delivery
Number of rescue norepinephrine	a bolus of norepinephrine was given when SBP decreased to <80% of the baseline value	Immediately to 20 minutes after subarachnoid block
APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	10min after delivery

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University
• Investigators: Study Chair: Xinli Ni, Dr., xinlini6@yahoo.com

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Hypotension; Norepinephrine; Cesarean Delivery; Inferior Vena Cava Collapsibility Index
• 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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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