Clinical trial

6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section: A Randomized Sequential Allocation Dose-finding Study

Name

Yi Chen-2022-2

Description

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.

Trial arms

Trial start

2024-02-01

Estimated PCD

2024-04-21

Trial end

2024-04-21

Status

Recruiting

Treatment

Hydroxyethyl starch 130/0.4

An initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 100 ml according to the responses of previous patients according to the up-down sequential allocation.

Arms:

Hydroxyethyl starch (130/0.4) coload group

Other names:

Colloid

Size

Primary endpoint

ED 50 and ED 90

1-15 minutes after spinal anesthesia

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-02-02

1 organization

1 product

1 indication

Organization

General Hospital of Ningxia Medical University

Product

Hydroxyethyl starch

Indication

Adverse Effect