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

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

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 Overview

• Status: Recruiting
• Conditions: Adverse Effect
• Intervention / Treatment: Drug: Hydroxyethyl starch 130/0.4

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Chen, M.D.; Phone Number: 86-951-674-3252; Email: czzyxgp@163.com

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Rui Qin, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Colloid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED 50 and ED 90	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	1-15 minutes after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of post-spinal anesthesia hypotension	Systolic blood pressure (SBP) < 80% of the baseline	1-15 minutes after spinal anesthesia
The incidence of severe post-spinal anesthesia hypotension.	Systolic blood pressure (SBP) < 60% of the baseline.	1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting.	Presence of nausea and vomiting in patients after spinal anesthesia	1-15 minutes after spinal anesthesia
The incidence of hypertension.	Systolic blood pressure (SBP) >120% of the baseline.	1-15 minutes after spinal anesthesia
pH	From umbilical arterial blood gases.	Immediately after delivery
APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	1 min after delivery
APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	5 min after delivery
The incidence of bradycardia.	Heart rate < 60 beats/min.	1-15 minutes after spinal anesthesia
Partial pressure of oxygen (PO2)	From umbilical arterial blood gases.	Immediately after delivery
Base excess (BE)	From umbilical arterial blood gases.	Immediately after delivery

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University
• Investigators: Study Chair: Yi Chen, M.D., General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): April 21, 2024
• Study Completion (Estimated): April 21, 2024

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hypotension; Cesarean section; Coload; Hydroxyethyl starch 130/0.4
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID Numbers: Yi Chen-2022-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No