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Crystalloid Versus Colloid Rapid Co-load for Cesarean Delivery Under Spinal Anesthesia

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Seoul National University

Status

Completed

Conditions

Hypotension
Cesarean Delivery
Pregnancy

Treatments

Other: Crystalloid
Other: Colloid

Study type

Interventional

Funder types

Other

Identifiers

NCT03729076
H-1807-152-961

Details and patient eligibility

About

The study aims to compare crystalloid co-loading and colloid co-loading in parturients receiving prophylactic phenylephrine infusion during cesarean delivery in terms of the incidence of hypotension.

Enrollment

100 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Healthy, full-term parturients who scheduled to undergo elective cesarean delivery under spinal anesthesia.

Exclusion criteria

  • multiple pregnancy

    • gestational age < 36 weeks

      • preexisting or pregnancy-induced hypertension

        • Morbid cardiovascular impairments

          • Cerebrovascular disease

            ⑥ Known fetal anomaly

            ⑦ Contraindications to spinal anesthesia

            ⑧ Any sign of onset of labor

            ⑨ Body weight < 45 kg or body weight > 90 kg

            ⑩ Height < 145cm or height > 180cm

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups

Crystalloid
Experimental group
Description:
Patients will receive rapid co-load of plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia.
Treatment:
Other: Crystalloid
Colloid
Active Comparator group
Description:
Patients will receive rapid co-load of 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia.
Treatment:
Other: Colloid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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