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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crystalloid | Experimental | Patients will receive rapid co-load of plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia. |
|
| Colloid | Active Comparator | Patients will receive rapid co-load of 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
multiple pregnancy
gestational age < 36 weeks
preexisting or pregnancy-induced hypertension
Morbid cardiovascular impairments
Cerebrovascular disease
â‘¥ 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
â‘© Height < 145cm or height > 180cm
Parturients
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, MD, PhD | Seoul National University Hospital, Seoul National University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29090733 | Background | 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. | |
| 25501602 |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D003102 | Colloids |
| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045424 | Complex Mixtures |
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| 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. |
|
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 |
| 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. |
| 29461392 | 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. |
| 27670627 | 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. |
| D004304 |
| Dosage Forms |