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

Adverse Effect Clinical Trial

Official title:

Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997500
• Other study ID #: Yi Chen
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 31, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Effect
• Hypotension

Intervention

Drug:
• normal saline
a bolus of normal saline was given followed by normal saline infusion
• Norepinephrine
a bolus of norepinephrine was given followed by norepinephrine infusion

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of hypotension	SBP decreased to <80% of the baseline value	1 to 20 minutes after subarachnoid block
Primary	Inferior vena cava collapsibility index	CI = (dIVCmax - dIVCmin)/dIVCmax	5 to 20 minutes after subarachnoid block
Secondary	The incidence of nausea and vomiting	Presence of nausea and vomiting in patients after subarachnoid block	1 to 20 minutes after subarachnoid block
Secondary	The incidence of bradycardia	Heart rate less than 55 bpm	1 to 20 minutes after subarachnoid block
Secondary	Incidence of hypertension	Systolic blood pressure at or above 120% of baseline	1 to 20 minutes after subarachnoid block
Secondary	Arterial base excess of fetal vein blood	From umbilical vein blood gases	Immediately after delivery
Secondary	Pressure of oxygen of fetal vein blood	From umbilical vein blood gases	Immediately after delivery
Secondary	pH value of fetal vein blood	From umbilical vein blood gases	Immediately after delivery
Secondary	Number of rescue norepinephrine	a bolus of norepinephrine was given when SBP decreased to <80% of the baseline value	Immediately to 20 minutes after subarachnoid block
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	1min after delivery
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	5min after delivery
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	10min after delivery