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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.
Eur J Anaesthesiol 2018; 35(5):390-397EJ

Abstract

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.

Authors+Show Affiliations

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).No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29373334

Citation

Sng, Ban Leong, et al. "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." European Journal of Anaesthesiology, vol. 35, no. 5, 2018, pp. 390-397.
Sng BL, Du W, Lee MX, et al. 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. Eur J Anaesthesiol. 2018;35(5):390-397.
Sng, B. L., Du, W., Lee, M. X., Ithnin, F., Mathur, D., Leong, W. L., ... Sia, A. T. H. (2018). 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. European Journal of Anaesthesiology, 35(5), pp. 390-397. doi:10.1097/EJA.0000000000000779.
Sng BL, et al. 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. Eur J Anaesthesiol. 2018;35(5):390-397. PubMed PMID: 29373334.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Sng,Ban Leong, AU - Du,Wei, AU - Lee,Man Xin, AU - Ithnin,Farida, AU - Mathur,Deepak, AU - Leong,Wan Ling, AU - Sultana,Rehena, AU - Han,Nian-Lin R, AU - Sia,Alex Tiong Heng, PY - 2018/1/27/pubmed PY - 2019/4/9/medline PY - 2018/1/27/entrez SP - 390 EP - 397 JF - European journal of anaesthesiology JO - Eur J Anaesthesiol VL - 35 IS - 5 N2 - 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. SN - 1365-2346 UR - https://www.unboundmedicine.com/medline/citation/29373334/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_ L2 - http://Insights.ovid.com/pubmed?pmid=29373334 DB - PRIME DP - Unbound Medicine ER -