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

General Hospital of Ningxia Medical University

Status: Completed

Conditions: Adverse Effect

Treatments: Drug: normal saline; Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03997500

Yi Chen

Details and patient eligibility

About

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).

Full 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).

Enrollment: 195 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 2 patient groups, including a placebo group

Normal saline

Placebo Comparator group

Description:

Simultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion

Treatment:

Drug: normal saline

Norepinephrine

Experimental group

Description:

Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion

Treatment:

Drug: Norepinephrine