Evaluating an advanced double intravenous vasopressor automated system to treat hypotension during spinal anesthesia for cesarean delivery: a randomized controlled trial. 2023

Hon Sen Tan, and Singaraselvan Nagarajan, and Jason Ju In Chan, and Chin Wen Tan, and Rehena Sultana, and Alex Tiong Heng Sia, and Ban Leong Sng
Department of Women's Anesthesia, KK Women's and Children's Hospital, Singapore, Singapore.

The optimal treatment of hypotension during spinal anaesthesia is uncertain. A novel double intravenous vasopressor automated (DIVA) system reduces hypotension compared to standard care, and was subsequently modified to an advanced-DIVA (ADIVA) system. The primary objective was to compare ADIVA versus DIVA on incidence of hypotension (systolic BP (SBP) < 80% baseline). We conducted a randomized-controlled trial in women undergoing elective cesarean delivery under spinal anesthesia. SBP and heart rate were measured continuously using a Nexfin monitor. ADIVA delivered 25 μg phenylephrine (heart rate > 60 beats.min-1) or 2 mg ephedrine (heart rate < 60 beats.min-1) at SBP 90 to 110% of baseline, 50 μg phenylephrine or 4 mg ephedrine at SBP 80 to 90%, and 75 μg phenylephrine or 6 mg ephedrine at SBP < 80%. ADIVA calculated the trend of SBP; vasopressors were administered rapidly if SBP trended downward, or 30 s if SBP trended upward. In contrast, DIVA delivered 25 μg phenylephrine or 2 mg ephedrine at SBP 90 to 100% of baseline, and 50 μg phenylephrine or 4 mg ephedrine at SBP < 90%. Boluses were followed by a 10-s lockout. Other outcomes included hypertension (SBP > 120% baseline), vasopressor consumption, clinical outcomes, and performance measures from spinal anesthesia to fetal delivery. We analyzed 94 parturients (ADIVA: n = 46, DIVA: n = 48), with no difference in the incidence of hypotension between ADIVA (78.3%) and DIVA (83.3%, p = 0.677). ADIVA had significantly higher proportion of hypotensive SBP readings, lower phenylephrine consumption and higher umbilical arterial pH. There was no difference in hypertension, bradycardia, ephedrine consumption, intravenous fluid volume, nausea/vomiting, Apgar scores, and umbilical venous pH or lactate. ADIVA maintained SBP higher above baseline with greater fluctuation than DIVA. ADIVA was associated with a greater proportion of hypotensive SBP readings, reduced phenylephrine consumption, and increased umbilical arterial pH than DIVA. Further research is needed to determine the optimal method of vasopressor delivery in parturients undergoing cesarean delivery. This study was registered on Clinicaltrials.gov registry (NCT03620942) on 08/08/2018.

UI MeSH Term Description Entries
D006973 Hypertension Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more. Blood Pressure, High,Blood Pressures, High,High Blood Pressure,High Blood Pressures
D007022 Hypotension Abnormally low BLOOD PRESSURE that can result in inadequate blood flow to the brain and other vital organs. Common symptom is DIZZINESS but greater negative impacts on the body occur when there is prolonged depravation of oxygen and nutrients. Blood Pressure, Low,Hypotension, Vascular,Low Blood Pressure,Vascular Hypotension
D010656 Phenylephrine An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent. (R)-3-Hydroxy-alpha-((methylamino)methyl)benzenemethanol,Metaoxedrin,Metasympatol,Mezaton,Neo-Synephrine,Neosynephrine,Phenylephrine Hydrochloride,Phenylephrine Tannate,Neo Synephrine,Tannate, Phenylephrine
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004809 Ephedrine A phenethylamine found in EPHEDRA SINICA. PSEUDOEPHEDRINE is an isomer. It is an alpha- and beta-adrenergic agonist that may also enhance release of norepinephrine. It has been used for asthma, heart failure, rhinitis, and urinary incontinence, and for its central nervous system stimulatory effects in the treatment of narcolepsy and depression. It has become less extensively used with the advent of more selective agonists. Ephedrine Hydrochloride,Ephedrine Renaudin,Ephedrine Sulfate,Erythro Isomer of Ephedrine,Sal-Phedrine,Ephedrine Erythro Isomer,Hydrochloride, Ephedrine,Renaudin, Ephedrine,Sal Phedrine,SalPhedrine,Sulfate, Ephedrine
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000773 Anesthesia, Obstetrical A variety of anesthetic methods such as EPIDURAL ANESTHESIA used to control the pain of childbirth. Anesthesia, Gynecological,Anesthesia, Obstetric,Gynecologic Anesthesia,Paracervical Block,Anesthesia, Gynecologic,Block, Paracervical,Blocks, Paracervical,Gynecological Anesthesia,Obstetric Anesthesia,Obstetrical Anesthesia,Paracervical Blocks
D000775 Anesthesia, Spinal Procedure in which an anesthetic is injected directly into the spinal cord. Anesthesias, Spinal,Spinal Anesthesia,Spinal Anesthesias

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