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

Not Applicable

Completed

• Conditions: Adverse Effect
• Interventions: Drug: normal saline; Drug: Norepinephrine

• Registration Number: NCT03997500
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

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).

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 Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Primary Completion: 2019-10-21
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 195

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	normal saline	Simultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion
Norepinephrine	Norepinephrine	Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China