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

Comparison of 6% Hydroxyethyl Starch (130/0.4) and Crystalloid Coload Combined With Prophylactic Norepinephrine Infusion for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section

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 Overview

• Status: Completed
• Conditions: Adverse Effect
• Intervention / Treatment: Drug: Hydroxyethyl starch; Drug: Crystalloid

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China
      • General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

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

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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroxyethyl starch coload group; 10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia	Drug: Hydroxyethyl starch; 10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.; Other Names: Colloid
Experimental: Crystalloid coload group; 10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.	Drug: Crystalloid; 10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED 50 and ED 90	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	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: Xiangzhao Xu, M.D.; Ph. D, The People's Hospital of Nanchuan

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): March 21, 2023
• Study Completion (Actual): March 21, 2023

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cesarean section; Crystalloid; Norepinephrine; Postspinal anesthesia hypotension; Coload; Hydroxyethyl starch 130/0.4
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: Yi Chen-2022-3

Drug and device information, study documents

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