Clinical trial NCT03997500: Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index
Official title: Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect
Keywords: Norepinephrine
Hypotension
Inferior Vena Cava Collapsibility Index
Cesarean Delivery
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 195
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: The incidence of hypotension
timeFrame: 1 to 20 minutes after subarachnoid block
measure: Inferior vena cava collapsibility index
timeFrame: 5 to 20 minutes after subarachnoid block
Secondary outcomes:
measure: The incidence of nausea and vomiting
timeFrame: 1 to 20 minutes after subarachnoid block
measure: The incidence of bradycardia
timeFrame: 1 to 20 minutes after subarachnoid block
measure: Incidence of hypertension
timeFrame: 1 to 20 minutes after subarachnoid block
measure: Arterial base excess of fetal vein blood
timeFrame: Immediately after delivery
measure: Pressure of oxygen of fetal vein blood
timeFrame: Immediately after delivery
measure: pH value of fetal vein blood
timeFrame: Immediately after delivery
measure: Number of rescue norepinephrine
timeFrame: Immediately to 20 minutes after subarachnoid block
measure: APGAR score
timeFrame: 1min after delivery
measure: APGAR score
timeFrame: 5min after delivery
measure: APGAR score
timeFrame: 10min after delivery
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: xinlini6@yahoo.com
name: Xinli Ni, Dr.
role: STUDY_CHAIR
References: