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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04432675
Other study ID # CINI-AD-20205-13
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 30, 2022
Est. completion date November 15, 2022

Study information

Verified date June 2020
Source China International Neuroscience Institution
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 15, 2022
Est. primary completion date November 15, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Healthy singleton pregnancy scheduled for elective cesarean section under CSEA; American Society of Anesthesiologists (ASA) physical status ?/?; 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


Related Conditions & MeSH terms


Intervention

Drug:
hydroxyethl starch
10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
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

Locations

Country Name City State
China Xuanwu hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
China International Neuroscience Institution

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary hypotension The incidence of maternal hypotension during the operation during operation procedure
Secondary umbilical vein blood gases umbilical vein blood gases 24 hours
Secondary umbilical artery blood gases umbilical artery blood gases 24 hours
Secondary Maternal vein blood gase Maternal vein blood gase 24 hours
Secondary The incidences of maternal complications The incidences of maternal complications such as hypotension, tachycardia, bandycardia, nausea and vomiting, breath difficulty, and dizzy perioperatively. 24 hours
Secondary Hemodynamic data at time point Hemodynamic data at time point 24 hours
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