Randomized Controlled Trial

. 2015 Jul;123(1):38-54.

doi: 10.1097/ALN.0000000000000709.

Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial

Collaborators, Affiliations

Collaborators

General Anesthesia compared to Spinal anesthesia (GAS) Consortium:
Andrew J Davidson, Geoff Frawley, Pollyanna Hardy, Sarah J Arnup, Katherine Lee, Rodney W Hunt, Robyn Stargatt, Suzette Sheppard, Gillian Ormond, Penelope Hartmann, Philip Ragg, Marie Backstrom, David Costi, Britta S von Ungern-Sternberg, Niall Wilton, Graham Knottenbelt, Nicola Disma, Giovanni Montobbio, Leila Mameli, Pietro Tuo, Gaia Giribaldi, Alessio Pini Prato, Girolamo Mattioli, Andrea Wolfler, Francesca Izzo, Ida Salvo, Valter Sonzogni, Bruno Guido Locatelli, Magda Khotcholava, Jurgen C de Graaff, Jose T D G van Gool, Sandra C Numan, Cor J Kalkman, J H M Hagenaars, Anthony R Absalom, Frouckje M Hoekstra, Martin J Volkers, Davinia E Withington, Koto Furue, Josee Gaudreault, Mary Ellen McCann, Charles Berde, Sulpicio Soriano, Vanessa Young, Navil Sethna, Pete Kovatsis, Joseph P Cravero, David Bellinger, Jacki Marmor, Anne Lynn, Iskra Ivanova, Agnes Hunyady, Shilpa Verma, David Polaner, Joss Thomas, Martin Meuller, Denisa Haret, Peter Szmuk, Jeffery Steiner, Brian Kravitz, Santhanam Suresh, Stephen R Hays, Andreas H Taenzer, Lynne G Maxwell, Robert K Williams, Neil S Morton, Graham T Bell, Liam Dorris, Claire Adey, Oliver Bagshaw, Anthony Chisakuta, Ayman Eissa, Peter Stoddart, Annette Davis, Paul Myles, Andrew J Davidson, Mary Ellen McCann, Neil S Morton, Nicola Disma, Davinia E Withington, Jurgen C de Graaff, Geoff Frawley, Rodney W Hunt, David Bellinger, Charles Berde, Andy Wolf, Neil McIntosh, John Carlin, Kate Leslie, Gillian Ormond, Pollyanna Hardy, Sarah J Arnup, Robyn Stargatt, Suzette Sheppard, Katherine Lee, Jonathan de Lima, Greg Hammer, David Field, Val Gebski, Dick Tibboel

Affiliation

¹ From the Anaesthesia and Pain Management Research Group, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia (A.J.D., G.F., G.O.); Department of Anaesthesia and Pain Management, The Royal Children's Hospital, Melbourne, Victoria, Australia (A.J.D., G.F.); Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia (A.J.D., G.F., R.W.H.); Academic Unit of Anaesthesia, Pain and Critical Care, University of Glasgow, Glasgow, United Kingdom (N.S.M.); Department of Anaesthesia, Royal Hospital for Sick Children, Glasgow, United Kingdom (N.S.M.); Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia (S.J.A.); Department of Anaesthesia, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands (J.C.d.G.); Department of Anesthesia, Istituto Giannina Gaslini, Genoa, Italy (N.D., P.T.); Department of Anaesthesia, Montreal Children's Hospital, Montreal, Quebec, Canada (D.E.W.); Department of Anesthesia, McGill University, Montreal, Quebec, Canada (D.E.W.); Department of Neonatal Medicine, The Royal Children's Hospital, Melbourne, Victoria, Australia (R.W.H.); Neonatal Research Group, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia (R.W.H.); National Perinatal Epidemiology Unit, Clinical Trials Unit, University of Oxford, Oxford, United Kingdom (P.H.); Department of Anaesthesia, Ospedale Papa Giovanni XXIII, Bergamo, Italy (M.K., B.G.L.); Pharmacology, Pharmacy, Anaesthesiology Unit, School of Medicine and Pharmacology, The University of Western Australia, Perth, Western Australia, Australia (B.S.v.U.S.); Department of Anaesthesia and Pain Management, Princess Margaret Hospital for Children, Perth, Western Australia, Australia (B.S.v.U.S.); Department of Paediatric Anaesthesia and Operating Rooms, Starship Children's Hospital, Auckland District Health Board, Auckland, New Zealand (N.W.); Department of Anesthesiology and Paedi

PMID: 26001033
PMCID: PMC4626294
DOI: 10.1097/ALN.0000000000000709

Randomized Controlled Trial

Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial

Andrew J Davidson et al. Anesthesiology. 2015 Jul.

. 2015 Jul;123(1):38-54.

doi: 10.1097/ALN.0000000000000709.

Collaborators

General Anesthesia compared to Spinal anesthesia (GAS) Consortium:
Andrew J Davidson, Geoff Frawley, Pollyanna Hardy, Sarah J Arnup, Katherine Lee, Rodney W Hunt, Robyn Stargatt, Suzette Sheppard, Gillian Ormond, Penelope Hartmann, Philip Ragg, Marie Backstrom, David Costi, Britta S von Ungern-Sternberg, Niall Wilton, Graham Knottenbelt, Nicola Disma, Giovanni Montobbio, Leila Mameli, Pietro Tuo, Gaia Giribaldi, Alessio Pini Prato, Girolamo Mattioli, Andrea Wolfler, Francesca Izzo, Ida Salvo, Valter Sonzogni, Bruno Guido Locatelli, Magda Khotcholava, Jurgen C de Graaff, Jose T D G van Gool, Sandra C Numan, Cor J Kalkman, J H M Hagenaars, Anthony R Absalom, Frouckje M Hoekstra, Martin J Volkers, Davinia E Withington, Koto Furue, Josee Gaudreault, Mary Ellen McCann, Charles Berde, Sulpicio Soriano, Vanessa Young, Navil Sethna, Pete Kovatsis, Joseph P Cravero, David Bellinger, Jacki Marmor, Anne Lynn, Iskra Ivanova, Agnes Hunyady, Shilpa Verma, David Polaner, Joss Thomas, Martin Meuller, Denisa Haret, Peter Szmuk, Jeffery Steiner, Brian Kravitz, Santhanam Suresh, Stephen R Hays, Andreas H Taenzer, Lynne G Maxwell, Robert K Williams, Neil S Morton, Graham T Bell, Liam Dorris, Claire Adey, Oliver Bagshaw, Anthony Chisakuta, Ayman Eissa, Peter Stoddart, Annette Davis, Paul Myles, Andrew J Davidson, Mary Ellen McCann, Neil S Morton, Nicola Disma, Davinia E Withington, Jurgen C de Graaff, Geoff Frawley, Rodney W Hunt, David Bellinger, Charles Berde, Andy Wolf, Neil McIntosh, John Carlin, Kate Leslie, Gillian Ormond, Pollyanna Hardy, Sarah J Arnup, Robyn Stargatt, Suzette Sheppard, Katherine Lee, Jonathan de Lima, Greg Hammer, David Field, Val Gebski, Dick Tibboel

Affiliation

¹ From the Anaesthesia and Pain Management Research Group, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia (A.J.D., G.F., G.O.); Department of Anaesthesia and Pain Management, The Royal Children's Hospital, Melbourne, Victoria, Australia (A.J.D., G.F.); Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia (A.J.D., G.F., R.W.H.); Academic Unit of Anaesthesia, Pain and Critical Care, University of Glasgow, Glasgow, United Kingdom (N.S.M.); Department of Anaesthesia, Royal Hospital for Sick Children, Glasgow, United Kingdom (N.S.M.); Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia (S.J.A.); Department of Anaesthesia, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands (J.C.d.G.); Department of Anesthesia, Istituto Giannina Gaslini, Genoa, Italy (N.D., P.T.); Department of Anaesthesia, Montreal Children's Hospital, Montreal, Quebec, Canada (D.E.W.); Department of Anesthesia, McGill University, Montreal, Quebec, Canada (D.E.W.); Department of Neonatal Medicine, The Royal Children's Hospital, Melbourne, Victoria, Australia (R.W.H.); Neonatal Research Group, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia (R.W.H.); National Perinatal Epidemiology Unit, Clinical Trials Unit, University of Oxford, Oxford, United Kingdom (P.H.); Department of Anaesthesia, Ospedale Papa Giovanni XXIII, Bergamo, Italy (M.K., B.G.L.); Pharmacology, Pharmacy, Anaesthesiology Unit, School of Medicine and Pharmacology, The University of Western Australia, Perth, Western Australia, Australia (B.S.v.U.S.); Department of Anaesthesia and Pain Management, Princess Margaret Hospital for Children, Perth, Western Australia, Australia (B.S.v.U.S.); Department of Paediatric Anaesthesia and Operating Rooms, Starship Children's Hospital, Auckland District Health Board, Auckland, New Zealand (N.W.); Department of Anesthesiology and Paedi

PMID: 26001033
PMCID: PMC4626294
DOI: 10.1097/ALN.0000000000000709

Abstract

Background: Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study is a randomized, controlled trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia.

Methods: Infants aged 60 weeks or younger, postmenstrual age scheduled for inguinal herniorrhaphy, were randomized to RA or GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born less than 26 weeks gestation. The primary outcome of this analysis was any observed apnea up to 12 h postoperatively. Apnea assessment was unblinded.

Results: Three hundred sixty-three patients were assigned to RA and 359 to GA. Overall, the incidence of apnea (0 to 12 h) was similar between arms (3% in RA and 4% in GA arms; odds ratio [OR], 0.63; 95% CI, 0.31 to 1.30, P = 0.2133); however, the incidence of early apnea (0 to 30 min) was lower in the RA arm (1 vs. 3%; OR, 0.20; 95% CI, 0.05 to 0.91; P = 0.0367). The incidence of late apnea (30 min to 12 h) was 2% in both RA and GA arms (OR, 1.17; 95% CI, 0.41 to 3.33; P = 0.7688). The strongest predictor of apnea was prematurity (OR, 21.87; 95% CI, 4.38 to 109.24), and 96% of infants with apnea were premature.

Conclusions: RA in infants undergoing inguinal herniorrhaphy reduces apnea in the early postoperative period. Cardiorespiratory monitoring should be used for all ex-premature infants.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

**Figure 1. Consort Flow Diagram**
Of the 70 protocol violations in the RA arm, 10 infants had a full GA with no awake-regional attempted, 37 had a full general anaesthetic after complete block failure, and 23 infants had a partly successful block requiring a short period of general anaesthesia or sedation. Participants who withdrew consent (n=1) or were randomised after surgery (n=2) were excluded from intention to treat analyses. GA= General Anesthesia; RA = Regional Anesthesia.

**Figure 2. Time to Apnoea Events in RA and GA**
Times of all apnoea events in all infants in RA and GA allocated groups with RA group further divided into those with no sedation or sevoflurane (closed circles), and those exposed to sevoflurane or sedation (closed squares). Each horizontal dashed line represents one infant. GA= General Anesthesia; RA = Regional Anesthesia.

See this image and copyright information in PMC

Comment in

Postoperative Apnea in Former Preterm Infants: General Anesthesia or Spinal Anesthesia--Do We Have an Answer?
Kurth CD, Coté CJ. Kurth CD, et al. Anesthesiology. 2015 Jul;123(1):15-7. doi: 10.1097/ALN.0000000000000710. Anesthesiology. 2015. PMID: 26001034 No abstract available.

References

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Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial

Collaborators

Affiliation

Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial

Authors

Collaborators

Affiliation

Abstract

Conflict of interest statement

Figures

Comment in

References

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MeSH terms

Grants and funding

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Full Text Sources

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Medical