Comparison of Hydroxyethyl Starch and Crystalloid Coload Combined With Norepinephrine Infusion for Hypotension

Not Applicable

Completed

• Conditions: Adverse Effect
• Interventions: Drug: Crystalloid; Drug: Hydroxyethyl starch

• Registration Number: NCT05475990
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

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. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Study Start: 2023-01-11
• Last Update Submitted: 2023-03-20
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crystalloid coload group	Crystalloid	10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.
Hydroxyethyl starch coload group	Hydroxyethyl starch	10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia

Primary Outcome Measures

Name	Time	Method
ED 50 and ED 90	1-15 minutes after spinal anesthesia	The dose of prophylactic norepinephrine combined with 10 ml/kg 6% Hydroxyethyl starch (130/0.4) or 10 ml/kg crystalloid coload that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China