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

NCT03729076 | Completed

• 1 other identifier: H-1807-152-961
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Cesarean Delivery; Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• incidence of severe hypotension

  during the time period from induction of spinal anesthesia until delivery

• incidence of symptomatic hypotension

  during the time period from induction of spinal anesthesia until delivery

• incidence of bradycardia

  during the time period from induction of spinal anesthesia until delivery

• incidence of Hypertension

  during the time period from induction of spinal anesthesia until delivery

• Minimum recorded Systolic Blood Pressure (Minimum SBP)

  during the time period from induction of spinal anesthesia until delivery

Study Arms (2)

Crystalloid

EXPERIMENTAL

Patients will receive rapid co-load of plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia.

Other: Crystalloid

Colloid

ACTIVE COMPARATOR

Patients will receive rapid co-load of 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia.

Other: Colloid

Interventions

Crystalloid OTHER

Patients will receive the rapid co-loading with plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.

Crystalloid

Colloid OTHER

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.

Colloid

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Parturients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (4)

• 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.

  PMID: 29090733 BACKGROUND

• 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.

  PMID: 25501602 BACKGROUND

• 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.

  PMID: 29461392 BACKGROUND

• 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.

  PMID: 27670627 BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Crystalloid Solutions; Colloids

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations; Complex Mixtures; Dosage Forms

Study Officials

• Jin-Tae Kim, MD, PhD

  Seoul National University Hospital, Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: November 2, 2018
• Study Start: November 16, 2018
• Primary Completion: January 8, 2020
• Study Completion: January 12, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)