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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03729076
• Other study ID #: H-1807-152-961
• Status: Completed
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: January 12, 2020

Study information

• Verified date: January 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 12, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

? Known fetal anomaly

? Contraindications to spinal anesthesia

? Any sign of onset of labor

? Body weight < 45 kg or body weight > 90 kg

? Height < 145cm or height > 180cm

Related Conditions & MeSH terms

• Cesarean Delivery
• Hypotension
• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View Citation

Ripollés Melchor J, Espinosa Á, Martínez Hurtado E, Casans Francés R, Navarro Pérez 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	incidence of bradycardia	Heart Rate (HR) <50 bpm	during the time period from induction of spinal anesthesia until delivery
Secondary	incidence of Hypertension	Systolic Blood Pressure (SBP)> 120% of baseline SBP	during the time period from induction of spinal anesthesia until delivery
Secondary	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
Secondary	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
Secondary	Cumulative duration of hypotension	duration of hypotension, minutes	during the time period from induction of spinal anesthesia until delivery
Secondary	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
Secondary	Total phenylephrine use	Cumulative dose of phenylephrine administered via continuous infusion, mcg	during the time period from induction of spinal anesthesia until delivery
Secondary	Rescue phenylephrine use	number of patients who require the rescue use of phenylephrine	during the time period from induction of spinal anesthesia until delivery
Secondary	Rescue ephedrine use	number of patients who require the rescue use of ephedrine	during the time period from induction of spinal anesthesia until delivery
Secondary	Atropine use	number of patients who require the rescue use of atropine	during the time period from induction of spinal anesthesia until delivery
Secondary	Incidence of nausea, vomiting	The incidence of nausea, vomiting	during the time period from induction of spinal anesthesia until delivery
Secondary	Incidence of dizziness, breathlessness	The incidence of dizziness, breathlessness	during the time period from induction of spinal anesthesia until delivery
Secondary	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
Secondary	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
Secondary	Umbilical arterial pH	pH of Umbilical Arterial blood gas analysis (ABGA) (fetal outcome)	immediately after delivery
Secondary	Umbilical arterial base excess	base excess of Umbilical ABGA (fetal outcome), mmol/L	immediately after delivery
Secondary	Umbilical arterial partial oxygen pressure (PO2)	partial oxygen pressure of Umbilical ABGA (fetal outcome), mmHg	immediately after delivery
Secondary	Umbilical arterial carbon dioxide partial pressure (PCO2)	carbon dioxide partial pressure of Umbilical ABGA (fetal outcome), mmHg	immediately after delivery