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

Adverse Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05475886
• Other study ID #: Yi Chen-2022-2
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: April 21, 2024

Study information

• Verified date: January 2024
• Source: General Hospital of Ningxia Medical University
• Contact: Yi Chen, M.D.
• Phone: 86-951-674-3252
• Email: czzyxgp[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 21, 2024
• Est. primary completion date: April 21, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Effect
• Hypotension

Intervention

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.

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

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