6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension

Not Applicable

Recruiting

• Conditions: Adverse Effect
• Interventions: Drug: Hydroxyethyl starch 130/0.4

• Registration Number: NCT05475886
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal 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. Colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension are still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Study Start: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-04-21
• Study Completion: 2024-04-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydroxyethyl starch (130/0.4) coload group	Hydroxyethyl starch 130/0.4	An initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
ED 50 and ED 90	1-15 minutes after spinal anesthesia	The dose of 6% Hydroxyethyl starch (130/0.4) that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients

Secondary Outcome Measures

Name	Time	Method
The incidence of hypertension.	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \>120% of the baseline.
The incidence of post-spinal anesthesia hypotension	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \< 80% of the baseline
The incidence of bradycardia.	1-15 minutes after spinal anesthesia	Heart rate \< 60 beats/min.
pH	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
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 nausea and vomiting.	1-15 minutes after spinal anesthesia	Presence of nausea and vomiting in patients after spinal anesthesia
Partial pressure of oxygen (PO2)	Immediately after delivery	From umbilical arterial blood gases.

Trial Locations

Locations (1)

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