Clinical trial NCT03729076: Crystalloid Versus Colloid Rapid Co-load for Cesarean Delivery Under Spinal Anesthesia
Official title: Crystalloid Versus Colloid Rapid Co-load in Parturients Receiving Prophylactic Phenylephrine Infusion During Cesarean Delivery Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Cesarean Delivery
Hypotension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of maternal hypotension
timeFrame: during the time period from induction of spinal anesthesia until delivery
Secondary outcomes:
measure: incidence of severe hypotension
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: incidence of symptomatic hypotension
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: incidence of bradycardia
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: incidence of Hypertension
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Minimum recorded Systolic Blood Pressure (Minimum SBP)
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Minimum recorded Heart Rate (Minimum HR)
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Cumulative duration of hypotension
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Onset time of hypotension
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Total phenylephrine use
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Rescue phenylephrine use
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Rescue ephedrine use
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Atropine use
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Incidence of nausea, vomiting
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Incidence of dizziness, breathlessness
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Cutaneous stellate ganglion sympathetic activity
timeFrame: during the time period from induction of spinal anesthesia until delivery
measure: Apgar Score, 1 min, 5 min (fetal outcome)
timeFrame: 1 min, 5 min after delivery
measure: Umbilical arterial pH
timeFrame: immediately after delivery
measure: Umbilical arterial base excess
timeFrame: immediately after delivery
measure: Umbilical arterial partial oxygen pressure (PO2)
timeFrame: immediately after delivery
measure: Umbilical arterial carbon dioxide partial pressure (PCO2)
timeFrame: immediately after delivery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital, Seoul National University College of Medicine
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.