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Effects of Crystal Solution and Colloid Solution on Mother and Fetus

C

China International Neuroscience Institution

Status and phase

Completed
Phase 4

Conditions

Cesarean Section
Parturition
Spinal Anesthesia

Treatments

Drug: hydroxyethl starch
Drug: Lactated Ringer's solution

Study type

Interventional

Funder types

Other

Identifiers

NCT04432675
CINI-AD-20205-13

Details and patient eligibility

About

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

Full 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

Enrollment

100 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups

hydroxyethl starch group
Experimental group
Description:
10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
Treatment:
Drug: hydroxyethl starch
The control group
Active Comparator group
Description:
10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution
Treatment:
Drug: Lactated Ringer's solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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