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

General Hospital of Ningxia Medical University195 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

195

Conditions

Adverse Effect

Interventions

normal salineDRUG

a bolus of normal saline was given followed by normal saline infusion

NorepinephrineDRUG

a bolus of norepinephrine was given followed by norepinephrine infusion

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Outcomes

Primary Outcomes

The incidence of hypotension

SBP decreased to \<80% of the baseline value

Time frame: 1 to 20 minutes after subarachnoid block

Inferior vena cava collapsibility index

CI = (dIVCmax - dIVCmin)/dIVCmax

Time frame: 5 to 20 minutes after subarachnoid block

Secondary Outcomes

The incidence of nausea and vomiting

Presence of nausea and vomiting in patients after subarachnoid block

Time frame: 1 to 20 minutes after subarachnoid block

The incidence of bradycardia

Heart rate less than 55 bpm

Time frame: 1 to 20 minutes after subarachnoid block

Incidence of hypertension

Systolic blood pressure at or above 120% of baseline

Time frame: 1 to 20 minutes after subarachnoid block

Arterial base excess of fetal vein blood

From umbilical vein blood gases

Time frame: Immediately after delivery

Pressure of oxygen of fetal vein blood

From umbilical vein blood gases

Time frame: Immediately after delivery

pH value of fetal vein blood

From umbilical vein blood gases

Time frame: Immediately after delivery

Number of rescue norepinephrine

Data from ClinicalTrials.gov

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