Comparison of Different HES Coload Volumes on the 90% ED of Norepinephrine

Not Applicable

Completed

• Conditions: Adverse Effect
• Interventions: Drug: Hydroxyethyl starch coload - 0 ml/kg; Drug: Hydroxyethyl starch coload - 5 ml/kg; Drug: Hydroxyethyl starch coload - 10 ml/kg

• Registration Number: NCT05712018
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for 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. Coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-03
• Study Start: 2023-10-20
• Status Verified: 2024-01
• Primary Completion: 2024-01-23
• Study Completion: 2024-01-23
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0 ml/kg Hydroxyethyl starch coload group	Hydroxyethyl starch coload - 0 ml/kg	No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia
5 ml/kg Hydroxyethyl starch coload group	Hydroxyethyl starch coload - 5 ml/kg	5 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.
10 ml/kg Hydroxyethyl starch coload group	Hydroxyethyl starch coload - 10 ml/kg	10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
ED 50	1-15 minutes after spinal anesthesia	The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) of patients
ED 90	1-15 minutes after spinal anesthesia	The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 90% (ED90) of patients

Secondary 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
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 bradycardia	1-15 minutes after spinal anesthesia	Heart rate \< 60 beats/min
The incidence of nausea and vomiting	1-15 minutes after spinal anesthesia	Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of hypertension	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \>120% of the baseline
pH	Immediately after delivery	From umbilical arterial blood gases
Partial pressure of oxygen (PO2)	Immediately after delivery	From umbilical arterial blood gases
Base excess (BE)	Immediately after delivery	From umbilical arterial blood gases
APGAR score	5 min after delivery	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

Trial Locations

Locations (1)

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