Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

Adverse Effect Clinical Trial

Official title:

Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section: A Randomized Sequential Allocation Dose-finding Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035888
• Other study ID #: Yi Chen-2021-6
• Status: Completed
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: January 3, 2023

Study information

• Verified date: September 2022
• 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 potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean section.

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. Vasopressor 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. However, few studies had been indicated the ED50 (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine bolus and its potency compared to phenylephrine for postspinal anesthesia hypotension in patients undergoing caesarean section. The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 18-45 years

• Primipara or multipara

• Singleton pregnancy =37 weeks

• American Society of Anesthesiologists physical status classification I to II

• Scheduled for 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 =180 mmHg

• Hemoglobin < 7g/dl

• Fetal distress, or known fetal developmental anomaly

Related Conditions & MeSH terms

• Adverse Effect
• Hypotension

Intervention

Drug:
• Phenylephrine
An initial prophylactic bolus dose of phenylephrine (37.5µg) simultaneous with spinal anesthesia. If the patient did not respond adequately to the current dose (SBP decreased to < 80% of baseline), the dose was considered to have failed and the subsequent dose for the following patient was increased to the next higher dose level. The dose administered to subsequent patients varied by increments or decrements of 12.5 µg according to the responses of previous patients according to the up-down sequential allocation.
• Norepinephrine
An initial prophylactic bolus dose of norepinephrine (3µg) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 µg according to the responses of previous patients according to the up-down sequential allocation.

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 dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients	Systolic blood pressure (SBP) < 80% of the baseline	1-15 minutes after spinal anesthesia
Secondary	The incidence of post-spinal anesthesia hypotension	Systolic blood pressure (SBP) < 80% of the baseline	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 bradycardia.	Heart rate < 60 beats/min.	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 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 (PO2)	From umbilical arterial blood gases.	Immediately after delivery
Secondary	Base excess (BE)	From umbilical arterial blood gases.	Immediately after delivery
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	1 min after delivery
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	5 min after delivery