Prophylactic Norepinephrine Infusion Combined With Colloid Coloading for Postspinal Anesthesia Hypotension

Not Applicable

Completed

• Conditions: Adverse Event
• Interventions: Drug: Norepinephrine (0.1 μg/kg/min); Drug: Norepinephrine (0.05 μg/kg/min); Drug: Norepinephrine (0.075 μg/kg/min); Drug: Norepinephrine (0.025 μg/kg/min); Drug: Normal saline

• Registration Number: NCT05133817
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.

Detailed 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. But the ideal infusion dose of norepinephrine with colloid coload is still unknown. The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-24
• Study Start: 2021-11-26
• Primary Completion: 2022-09-03
• Study Completion: 2022-09-03
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 175

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
• Coagulation or renal function disorders
• Known allergy to hydroxyethyl starch
• Fetal distress, or known fetal developmental anomaly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.1μg/kg/min group	Norepinephrine (0.1 μg/kg/min)	Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.1μg/kg/min) by IV infusion.
0.05 μg/kg/min group	Norepinephrine (0.05 μg/kg/min)	Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.05 μg/kg/min) by IV infusion.
0.075 μg/kg/min group	Norepinephrine (0.075 μg/kg/min)	Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.075 μg/kg/min) by IV infusion.
0.025 μg/kg/min group	Norepinephrine (0.025 μg/kg/min)	Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.025 μg/kg/min) by IV infusion.
Control group	Normal saline	Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.

Primary Outcome Measures

Name	Time	Method
The incidence of post-spinal anesthesia hypotension	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \< 80% of the baseline

Secondary Outcome Measures

Name	Time	Method
The incidence of severe post-spinal anesthesia hypotension.	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \< 60% of the baseline.
The incidence of hypertension.	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \>120% of the baseline.
Concentration of base excess	Immediately after fetal delivery	Analyse from umbilical arterial blood gases.
Apgar score (0-10; a higher score means a better outcome)	5 min after fetal delivery	A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)
The incidence of bradycardia.	1-15 minutes after spinal anesthesia	Heart rate \< 55 beats/min.
Partial pressure of oxygen	Immediately after fetal delivery	Analyse from umbilical arterial blood gases.
Overall stability of systolic blood pressure control versus baseline	1-15 minutes after spinal anesthesia	Evaluated by performance error (PE).
The incidence of nausea and vomiting.	1-15 minutes after spinal anesthesia	Presence of nausea and vomiting in patients after spinal anesthesia
pH value	Immediately after fetal delivery	Analyse from umbilical arterial blood gases.
Apgar score (0-10;a higher score means a better outcome)	5 min after fetal delivery	A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China