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

Study Overview
=================
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.

Official Title
-----------------
Crystalloid Versus Colloid Rapid Co-load in Parturients Receiving Prophylactic Phenylephrine Infusion During Cesarean Delivery Under Spinal Anesthesia

Conditions
-----------------
Pregnancy, Cesarean Delivery, Hypotension

Intervention / Treatment
-----------------
* Other: Crystalloid
* Other: Colloid


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crystalloid<br>Patients will receive rapid co-load of plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia. | Other: Crystalloid<br>* Patients will receive the rapid co-loading with plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.<br>|
| Active Comparator: Colloid<br>Patients will receive rapid co-load of 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia. | Other: Colloid<br>* Patients will receive the rapid co-loading with 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of maternal hypotension | defined as: Systolic Blood Pressure (SBP) < 80% of baseline SBP | during the time period from induction of spinal anesthesia until delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of severe hypotension | defined as: Systolic Blood Pressure (SBP) < 70% of baseline SBP | during the time period from induction of spinal anesthesia until delivery | 
| incidence of symptomatic hypotension | defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness | during the time period from induction of spinal anesthesia until delivery | 
| incidence of bradycardia | Heart Rate (HR) <50 bpm | during the time period from induction of spinal anesthesia until delivery | 
| incidence of Hypertension | Systolic Blood Pressure (SBP)> 120% of baseline SBP | during the time period from induction of spinal anesthesia until delivery | 
| Minimum recorded Systolic Blood Pressure (Minimum SBP) | The lowest recorded SBP during the time period from induction of spinal anesthesia until delivery | during the time period from induction of spinal anesthesia until delivery | 
| Minimum recorded Heart Rate (Minimum HR) | The lowest recorded HR during the time period from induction of spinal anesthesia until delivery | during the time period from induction of spinal anesthesia until delivery | 
| Cumulative duration of hypotension | duration of hypotension, minutes | during the time period from induction of spinal anesthesia until delivery | 
| Onset time of hypotension | Time from the induction of spinal anesthesia until the first event of hypotension occur | during the time period from induction of spinal anesthesia until delivery | 
| Total phenylephrine use | Cumulative dose of phenylephrine administered via continuous infusion, mcg | during the time period from induction of spinal anesthesia until delivery | 
| Rescue phenylephrine use | number of patients who require the rescue use of phenylephrine | during the time period from induction of spinal anesthesia until delivery | 
| Rescue ephedrine use | number of patients who require the rescue use of ephedrine | during the time period from induction of spinal anesthesia until delivery | 
| Atropine use | number of patients who require the rescue use of atropine | during the time period from induction of spinal anesthesia until delivery | 
| Incidence of nausea, vomiting | The incidence of nausea, vomiting | during the time period from induction of spinal anesthesia until delivery | 
| Incidence of dizziness, breathlessness | The incidence of dizziness, breathlessness | during the time period from induction of spinal anesthesia until delivery | 
| Cutaneous stellate ganglion sympathetic activity | noninvasive recording of skin sympathetic nerve activity (SKNA) using conventional ECG electrodes | during the time period from induction of spinal anesthesia until delivery | 
| Apgar Score, 1 min, 5 min (fetal outcome) | 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. | 1 min, 5 min after delivery | 
| Umbilical arterial pH | pH of Umbilical Arterial blood gas analysis (ABGA) (fetal outcome) | immediately after delivery | 
| Umbilical arterial base excess | base excess of Umbilical ABGA (fetal outcome), mmol/L | immediately after delivery | 
| Umbilical arterial partial oxygen pressure (PO2) | partial oxygen pressure of Umbilical ABGA (fetal outcome), mmHg | immediately after delivery | 
| Umbilical arterial carbon dioxide partial pressure (PCO2) | carbon dioxide partial pressure of Umbilical ABGA (fetal outcome), mmHg | immediately after delivery |