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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Hypotension; Cesarean Delivery
• Intervention / Treatment: Other: Crystalloid; Other: Colloid

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jin-Tae Kim, MD, PhD, Seoul National University Hospital, Seoul National University College of Medicine

Publications and helpful links

General Publications

• Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
• Ripolles Melchor J, Espinosa A, Martinez Hurtado E, Casans Frances R, Navarro Perez R, Abad Gurumeta A, Calvo Vecino JM. Colloids versus crystalloids in the prevention of hypotension induced by spinal anesthesia in elective cesarean section. A systematic review and meta-analysis. Minerva Anestesiol. 2015 Sep;81(9):1019-30. Epub 2014 Dec 11.
• Tawfik MM, Tarbay AI, Elaidy AM, Awad KA, Ezz HM, Tolba MA. Combined Colloid Preload and Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2019 Feb;128(2):304-312. doi: 10.1213/ANE.0000000000003306.
• Doytchinova A, Hassel JL, Yuan Y, Lin H, Yin D, Adams D, Straka S, Wright K, Smith K, Wagner D, Shen C, Salanova V, Meshberger C, Chen LS, Kincaid JC, Coffey AC, Wu G, Li Y, Kovacs RJ, Everett TH 4th, Victor R, Cha YM, Lin SF, Chen PS. Simultaneous noninvasive recording of skin sympathetic nerve activity and electrocardiogram. Heart Rhythm. 2017 Jan;14(1):25-33. doi: 10.1016/j.hrthm.2016.09.019. Epub 2016 Sep 23.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2018
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): January 12, 2020

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: H-1807-152-961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No