Effects of Crystal Solution and Colloid Solution on Mother and Fetus

Phase 4

Completed

• Conditions: Parturition; Spinal Anesthesia; Cesarean Section
• Interventions: Drug: hydroxyethl starch; Drug: Lactated Ringer's solution

• Registration Number: NCT04432675
• Lead Sponsor: China International Neuroscience Institution

Brief Summary

Comparison of the effects of crystal solution (lactic acid Ringer's solution) and colloid solution (hydroxyethyl starch) on mother and fetus after cesarean section

Detailed Description

The Hydroxyethl group use 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch. The control group 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution. During the whole operation of elective cesarean section

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-13
• Study First Posted: 2020-06-16
• Study Start: 2022-01-30
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Healthy singleton pregnancy scheduled for elective cesarean section under CSEA; American Society of Anesthesiologists (ASA) physical status Ⅰ/Ⅱ; Age ranging from 20 to 40 years old.

Exclusion Criteria

• History of mental disorder or epilepsy; History of central nervous system (CNS) disease; Preexisting or pregnancy-induced hypertension; History of lumber injury; Severe hypovolemia; Allergy or hypersensitivity to norepinephrine; Body mass index (BMI) above 40 kg/m2; Infection at the puncture site; Tricyclic or imipramine antidepressants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydroxyethl starch group	hydroxyethl starch	10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
The control group	Lactated Ringer's solution	10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution

Primary Outcome Measures

Name	Time	Method
hypotension	during operation procedure	The incidence of maternal hypotension during the operation

Secondary Outcome Measures

Name	Time	Method
umbilical vein blood gases	24 hours	umbilical vein blood gases
umbilical artery blood gases	24 hours	umbilical artery blood gases
Hemodynamic data at time point	24 hours	Hemodynamic data at time point
Maternal vein blood gase	24 hours	Maternal vein blood gase
The incidences of maternal complications	24 hours	The incidences of maternal complications such as hypotension, tachycardia, bandycardia, nausea and vomiting, breath difficulty, and dizzy perioperatively.

Trial Locations

Locations (1)

Xuanwu hospital; 🇨🇳 Beijing, Beijing, China