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

NCT ID: NCT05475886

Last Updated: 2024-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-04-21

Brief Summary

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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

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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.

Conditions

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Adverse Effect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydroxyethyl starch (130/0.4) coload group

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

Group Type EXPERIMENTAL

Hydroxyethyl starch 130/0.4

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Colloid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi Chen, M.D.

Role: STUDY_CHAIR

General Hospital of Ningxia Medical University

Locations

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General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Chen, M.D.

Role: CONTACT

86-951-674-3252

Facility Contacts

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Rui Qin, M.D.

Role: primary

Other Identifiers

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Yi Chen-2022-2

Identifier Type: -

Identifier Source: org_study_id

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