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Comparison of double intravenous vasopressor automated system using nexfin versus manual vasopressor bolus administration for maintenance of haemodynamic stability during spinal anaesthesia for caesarean delivery: A randomised double-blind controlled trial

Sng, Ban, Leong; Du, Wei; Lee, Man, Xin; Ithnin, Farida; Mathur, Deepak; Leong, Wan, Ling; Sultana, Rehena; Han, Nian-Lin, R.; Sia, Alex Tiong, Heng

European Journal of Anaesthesiology: May 2018 - Volume 35 - Issue 5 - p 390–397
doi: 10.1097/EJA.0000000000000779
Obstetric anaesthesia
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BACKGROUND Hypotension is a common side effect of spinal anaesthesia during caesarean delivery and is associated with maternal and foetal adverse effects. We developed an updated double intravenous vasopressor automated (DIVA) system that administers phenylephrine or ephedrine based on continuous noninvasive haemodynamic monitoring using the Nexfin device.

OBJECTIVE The aim of our present study is to compare the performance and reliability of the DIVA system against Manual Vasopressor Bolus administration.

DESIGN A randomised, double-blind controlled trial.

SETTING Single-centre, KK Women's and Children's Hospital, Singapore.

PATIENTS Two hundred and thirty-six healthy women undergoing elective caesarean delivery under spinal anaesthesia.

MAIN OUTCOME MEASURES The primary outcome was the incidence of maternal hypotension. The secondary outcome measures were reactive hypertension, total vasopressor requirement and maternal and neonatal outcomes.

RESULTS The DIVA group had a significantly lower incidence of maternal hypotension, with 39.3% (46 of 117) patients having any SBP reading less than 80% of baseline compared with 57.5% (65 of 113) in the manual vasopressor bolus group (P = 0.008). The DIVA group also had fewer hypotensive episodes than the manual vasopressor bolus group (4.67 versus 7.77%; P < 0.0001). There was no difference in the incidence of reactive hypertension or the total vasopressor requirement. The DIVA group had less wobble in system performance. Maternal and neonatal outcomes were similar.

CONCLUSION The DIVA system achieved better control of maternal blood pressure after spinal anaesthesia than manual vasopressor bolus administration.

TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT02277730.

From the Department of Women's Anaesthesia, KK Women's and Children's Hospital (BLS, FI, DM, ATHS, WLL), Duke-NUS Medical School, Singapore (BLS, ATHS), Ministry of Health (WD, MXL), Centre for Quantitative Medicine, Duke-NUS Medical School (RS), and Division of Clinical Support Services, KK Women's and Children's Hospital, Singapore, Singapore (N-LRH)

Correspondence to Ban Leong Sng, Associate Professor, Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore Tel: +65 63941077; fax: +65 62912661; e-mail: sng.ban.leong@singhealth.com.sg

Published online 25 January 2018

© 2018 European Society of Anaesthesiology