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

General Hospital of Ningxia Medical University

Status: Enrolling

Conditions: Adverse Effect

Treatments: Drug: Hydroxyethyl starch 130/0.4

Study type: Interventional

Funder types: Other

Identifiers

NCT05475886

Yi Chen-2022-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Hydroxyethyl starch (130/0.4) coload group

Experimental group

Description:

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

Treatment:

Drug: Hydroxyethyl starch 130/0.4