Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

Adverse Effect Clinical Trial

Official title:

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04272567
• Other study ID #: Yi Chen-2020-1
• Status: Completed
• Phase: N/A
• Start date: March 28, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2020
• 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 suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

Description:

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18-40 years

• Primipara or multipara

• Singleton pregnancy =37 weeks

• American Society of Anesthesiologists physical status classification I to II

• Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

• Body height < 150 cm

• Body weight > 100 kg or body mass index (BMI) = 40 kg/m2

• Eclampsia or chronic hypertension or baseline blood pressure = 160mmHg

• Hemoglobin < 7g/dl

• Fetal distress, or known fetal developmental anomaly

Related Conditions & MeSH terms

• Adverse Effect
• Hypotension

Intervention

Drug:
• Norepinephrine
Simultaneous with subarachnoid block, a bolus of 6µg norepinephrine was given followed by different infusion dose of norepinephrine.
• Normal saline
Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline 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 post-spinal anesthesia hypotension	Systolic blood pressure (SBP) < 80% of the baseline	1-15 minutes after spinal anesthesia.
Secondary	Overall stability of systolic blood pressure control versus baseline	Evaluated by performance error (PE).	1-15 minutes after spinal anesthesia.
Secondary	Overall stability of heart rate control versus baseline	Evaluated by performance error (PE).	1-15 minutes after spinal anesthesia.
Secondary	The incidence of severe post-spinal anesthesia hypotension.	Systolic blood pressure (SBP) < 60% of the baseline.	1-15 minutes after spinal anesthesia.
Secondary	The incidence of nausea and vomiting.	Presence of nausea and vomiting in patients after spinal anesthesia	1-15 minutes after spinal anesthesia.
Secondary	The incidence of bradycardia.	Heart rate < 55 beats/min.	1-15 minutes after spinal anesthesia.
Secondary	The incidence of hypertension.	Systolic blood pressure (SBP) >120% of the baseline.	1-15 minutes after spinal anesthesia.
Secondary	pH	From umbilical arterial blood gases.	Immediately after delivery.
Secondary	Partial pressure of oxygen	From umbilical arterial blood gases.	Immediately after delivery.
Secondary	Base excess	From umbilical arterial blood gases.	Immediately after delivery.
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