Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Norepinephrine
- Conditions
- Adverse Effect
- Sponsor
- General Hospital of Ningxia Medical University
- Enrollment
- 195
- Locations
- 1
- Primary Endpoint
- The incidence of hypotension
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Norepinephrine
Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion
Intervention: Norepinephrine
Normal saline
Simultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion
Intervention: normal saline
Outcomes
Primary Outcomes
The incidence of hypotension
Time Frame: 1 to 20 minutes after subarachnoid block
SBP decreased to \<80% of the baseline value
Inferior vena cava collapsibility index
Time Frame: 5 to 20 minutes after subarachnoid block
CI = (dIVCmax - dIVCmin)/dIVCmax
Secondary Outcomes
- Arterial base excess of fetal vein blood(Immediately after delivery)
- Incidence of hypertension(1 to 20 minutes after subarachnoid block)
- Number of rescue norepinephrine(Immediately to 20 minutes after subarachnoid block)
- APGAR score(10min after delivery)
- The incidence of nausea and vomiting(1 to 20 minutes after subarachnoid block)
- The incidence of bradycardia(1 to 20 minutes after subarachnoid block)
- Pressure of oxygen of fetal vein blood(Immediately after delivery)
- pH value of fetal vein blood(Immediately after delivery)