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

Not Applicable

Completed

• Conditions: Cesarean Delivery; Pregnancy; Hypotension
• Interventions: Other: Crystalloid; Other: Colloid

• Registration Number: NCT03729076
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-28
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Study Start: 2018-11-16
• Status Verified: 2020-01
• Primary Completion: 2020-01-08
• Study Completion: 2020-01-12
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crystalloid	Crystalloid	Patients will receive rapid co-load of plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia.
Colloid	Colloid	Patients will receive rapid co-load of 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
Incidence of maternal hypotension	during the time period from induction of spinal anesthesia until delivery	defined as: Systolic Blood Pressure (SBP) \< 80% of baseline SBP

Secondary Outcome Measures

Name	Time	Method
Atropine use	during the time period from induction of spinal anesthesia until delivery	number of patients who require the rescue use of atropine
incidence of symptomatic hypotension	during the time period from induction of spinal anesthesia until delivery	defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness
incidence of severe hypotension	during the time period from induction of spinal anesthesia until delivery	defined as: Systolic Blood Pressure (SBP) \< 70% of baseline SBP
incidence of bradycardia	during the time period from induction of spinal anesthesia until delivery	Heart Rate (HR) \<50 bpm
incidence of Hypertension	during the time period from induction of spinal anesthesia until delivery	Systolic Blood Pressure (SBP)\> 120% of baseline SBP
Cumulative duration of hypotension	during the time period from induction of spinal anesthesia until delivery	duration of hypotension, minutes
Onset time of hypotension	during the time period from induction of spinal anesthesia until delivery	Time from the induction of spinal anesthesia until the first event of hypotension occur
Rescue phenylephrine use	during the time period from induction of spinal anesthesia until delivery	number of patients who require the rescue use of phenylephrine
Apgar Score, 1 min, 5 min (fetal outcome)	1 min, 5 min after delivery	Apgar Score of delivered baby. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are the Appearance, Pulse, Grimace, Activity, and Respiration. Each is scored on a scale of 0 to 2, with 2 being the best score. The test is done at 1 and 5 minutes after birth.
Umbilical arterial base excess	immediately after delivery	base excess of Umbilical ABGA (fetal outcome), mmol/L
Cutaneous stellate ganglion sympathetic activity	during the time period from induction of spinal anesthesia until delivery	noninvasive recording of skin sympathetic nerve activity (SKNA) using conventional ECG electrodes
Minimum recorded Systolic Blood Pressure (Minimum SBP)	during the time period from induction of spinal anesthesia until delivery	The lowest recorded SBP during the time period from induction of spinal anesthesia until delivery
Rescue ephedrine use	during the time period from induction of spinal anesthesia until delivery	number of patients who require the rescue use of ephedrine
Incidence of nausea, vomiting	during the time period from induction of spinal anesthesia until delivery	The incidence of nausea, vomiting
Incidence of dizziness, breathlessness	during the time period from induction of spinal anesthesia until delivery	The incidence of dizziness, breathlessness
Minimum recorded Heart Rate (Minimum HR)	during the time period from induction of spinal anesthesia until delivery	The lowest recorded HR during the time period from induction of spinal anesthesia until delivery
Total phenylephrine use	during the time period from induction of spinal anesthesia until delivery	Cumulative dose of phenylephrine administered via continuous infusion, mcg
Umbilical arterial pH	immediately after delivery	pH of Umbilical Arterial blood gas analysis (ABGA) (fetal outcome)
Umbilical arterial partial oxygen pressure (PO2)	immediately after delivery	partial oxygen pressure of Umbilical ABGA (fetal outcome), mmHg
Umbilical arterial carbon dioxide partial pressure (PCO2)	immediately after delivery	carbon dioxide partial pressure of Umbilical ABGA (fetal outcome), mmHg

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of