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1. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial

Author

Mccann, Mary Ellen, De Graaff, Jurgen C, Dorris, Liam, Disma, Nicola, Withington, Davinia, Bell, Graham, Grobler, Anneke, Stargatt, Robyn, Hunt, Rodney W, Sheppard, Suzette J, Marmor, Jacki, Giribaldi, Gaia, Bellinger, David, Hartmann, Penelope L, Hardy, Pollyanna, Frawley, Geoff, Izzo, Francesca, Von Ungern-sternberg, Britta, Lynn, Anne, Wilton, Niall, Mueller, Martin, Polaner, David M, Absalom, Anthony R, Szmuk, Peter, Morton, Neil S, Berde, Charles, Soriano, Sulpicio, Davidson, Andrew J, Arnup, Sarah, Lee, Katherine, Hunt, Rod W, Ormond, Gillian D, Takagi, Michael J, Taylor, Kaitlyn, Malarbi, Stephanie, Doyle, Melissa, Ragg, Philip, Costi, David, Wilton, Niall C, Knottenbelt, Graham, Furue, Koto, Gagnon, Hélène, Mameli, Leila, Pini Prato, Alessio, Mattioli, Girolamo, Wolfler, Andrea, Bova, Stefania M, Krachmalnicoff, Arianna, Guuva, Claudia, Van Der Werff, Desiree Bm, Van Gool, Jose Tdg, Van Loon, Kim, Kalkman, Cor J, Van Baar, Anneloes L, Hoekstra, Frouckje M, Volkers, Martin, Oostra, Martine, Pownall, Jaycee, Waldman, Jack, Hind, Ruth, Symonds, Joseph D, Bagshaw, Oliver, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Haret, Denisa, Steiner, Jeffrey, Kravitz, Brian, Farrow-gillespie, Alan, Suresh, Santhanam, Hays, Stephen, Taenzer, Andreas, Maxwell, Lynne, Williams, Robert, Mccann, Mary Ellen, De Graaff, Jurgen C, Dorris, Liam, Disma, Nicola, Withington, Davinia, Bell, Graham, Grobler, Anneke, Stargatt, Robyn, Hunt, Rodney W, Sheppard, Suzette J, Marmor, Jacki, Giribaldi, Gaia, Bellinger, David, Hartmann, Penelope L, Hardy, Pollyanna, Frawley, Geoff, Izzo, Francesca, Von Ungern-sternberg, Britta, Lynn, Anne, Wilton, Niall, Mueller, Martin, Polaner, David M, Absalom, Anthony R, Szmuk, Peter, Morton, Neil S, Berde, Charles, Soriano, Sulpicio, Davidson, Andrew J, Arnup, Sarah, Lee, Katherine, Hunt, Rod W, Ormond, Gillian D, Takagi, Michael J, Taylor, Kaitlyn, Malarbi, Stephanie, Doyle, Melissa, Ragg, Philip, Costi, David, Wilton, Niall C, Knottenbelt, Graham, Furue, Koto, Gagnon, Hélène, Mameli, Leila, Pini Prato, Alessio, Mattioli, Girolamo, Wolfler, Andrea, Bova, Stefania M, Krachmalnicoff, Arianna, Guuva, Claudia, Van Der Werff, Desiree Bm, Van Gool, Jose Tdg, Van Loon, Kim, Kalkman, Cor J, Van Baar, Anneloes L, Hoekstra, Frouckje M, Volkers, Martin, Oostra, Martine, Pownall, Jaycee, Waldman, Jack, Hind, Ruth, Symonds, Joseph D, Bagshaw, Oliver, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Haret, Denisa, Steiner, Jeffrey, Kravitz, Brian, Farrow-gillespie, Alan, Suresh, Santhanam, Hays, Stephen, Taenzer, Andreas, Maxwell, Lynne, and Williams, Robert

Abstract

Background In laboratory animals, exposure to most general anaesthetics leads to neurotoxicity manifested by neuronal cell death and abnormal behaviour and cognition. Some large human cohort studies have shown an association between general anaesthesia at a young age and subsequent neurodevelopmental deficits, but these studies are prone to bias. Others have found no evidence for an association. We aimed to establish whether general anaesthesia in early infancy affects neurodevelopmental outcomes. Methods In this international, assessor-masked, equivalence, randomised, controlled trial conducted at 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand, we recruited infants of less than 60 weeks' postmenstrual age who were born at more than 26 weeks' gestation and were undergoing inguinal herniorrhaphy, without previous exposure to general anaesthesia or risk factors for neurological injury. Patients were randomly assigned (1:1) by use of a web-based randomisation service to receive either awake-regional anaesthetic or sevoflurane-based general anaesthetic. Anaesthetists were aware of group allocation, but individuals administering the neurodevelopmental assessments were not. Parents were informed of their infants group allocation upon request, but were told to mask this information from assessors. The primary outcome measure was full-scale intelligence quotient (FSIQ) on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III), at 5 years of age. The primary analysis was done on a per-protocol basis, adjusted for gestational age at birth and country, with multiple imputation used to account for missing data. An intention-to-treat analysis was also done. A difference in means of 5 points was predefined as the clinical equivalence margin. This completed trial is registered with ANZCTR, number ACTRN12606000441516, and ClinicalTrials.gov, number NCT00756600. Findings Between F

Published
2019

2. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial

Author

Leerstoel Baar, Development and Treatment of Psychosocial Problems, Mccann, Mary Ellen, De Graaff, Jurgen C, Dorris, Liam, Disma, Nicola, Withington, Davinia, Bell, Graham, Grobler, Anneke, Stargatt, Robyn, Hunt, Rodney W, Sheppard, Suzette J, Marmor, Jacki, Giribaldi, Gaia, Bellinger, David, Hartmann, Penelope L, Hardy, Pollyanna, Frawley, Geoff, Izzo, Francesca, Von Ungern-sternberg, Britta, Lynn, Anne, Wilton, Niall, Mueller, Martin, Polaner, David M, Absalom, Anthony R, Szmuk, Peter, Morton, Neil S, Berde, Charles, Soriano, Sulpicio, Davidson, Andrew J, Arnup, Sarah, Lee, Katherine, Hunt, Rod W, Ormond, Gillian D, Takagi, Michael J, Taylor, Kaitlyn, Malarbi, Stephanie, Doyle, Melissa, Ragg, Philip, Costi, David, Wilton, Niall C, Knottenbelt, Graham, Furue, Koto, Gagnon, Hélène, Mameli, Leila, Pini Prato, Alessio, Mattioli, Girolamo, Wolfler, Andrea, Bova, Stefania M, Krachmalnicoff, Arianna, Guuva, Claudia, Van Der Werff, Desiree Bm, Van Gool, Jose Tdg, Van Loon, Kim, Kalkman, Cor J, Van Baar, Anneloes L, Hoekstra, Frouckje M, Volkers, Martin, Oostra, Martine, Pownall, Jaycee, Waldman, Jack, Hind, Ruth, Symonds, Joseph D, Bagshaw, Oliver, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Haret, Denisa, Steiner, Jeffrey, Kravitz, Brian, Farrow-gillespie, Alan, Suresh, Santhanam, Hays, Stephen, Taenzer, Andreas, Maxwell, Lynne, Williams, Robert, Leerstoel Baar, Development and Treatment of Psychosocial Problems, Mccann, Mary Ellen, De Graaff, Jurgen C, Dorris, Liam, Disma, Nicola, Withington, Davinia, Bell, Graham, Grobler, Anneke, Stargatt, Robyn, Hunt, Rodney W, Sheppard, Suzette J, Marmor, Jacki, Giribaldi, Gaia, Bellinger, David, Hartmann, Penelope L, Hardy, Pollyanna, Frawley, Geoff, Izzo, Francesca, Von Ungern-sternberg, Britta, Lynn, Anne, Wilton, Niall, Mueller, Martin, Polaner, David M, Absalom, Anthony R, Szmuk, Peter, Morton, Neil S, Berde, Charles, Soriano, Sulpicio, Davidson, Andrew J, Arnup, Sarah, Lee, Katherine, Hunt, Rod W, Ormond, Gillian D, Takagi, Michael J, Taylor, Kaitlyn, Malarbi, Stephanie, Doyle, Melissa, Ragg, Philip, Costi, David, Wilton, Niall C, Knottenbelt, Graham, Furue, Koto, Gagnon, Hélène, Mameli, Leila, Pini Prato, Alessio, Mattioli, Girolamo, Wolfler, Andrea, Bova, Stefania M, Krachmalnicoff, Arianna, Guuva, Claudia, Van Der Werff, Desiree Bm, Van Gool, Jose Tdg, Van Loon, Kim, Kalkman, Cor J, Van Baar, Anneloes L, Hoekstra, Frouckje M, Volkers, Martin, Oostra, Martine, Pownall, Jaycee, Waldman, Jack, Hind, Ruth, Symonds, Joseph D, Bagshaw, Oliver, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Haret, Denisa, Steiner, Jeffrey, Kravitz, Brian, Farrow-gillespie, Alan, Suresh, Santhanam, Hays, Stephen, Taenzer, Andreas, Maxwell, Lynne, and Williams, Robert

Published
2019

3. 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

Author

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

Subjects
Male, Internationality, Spinal, Apnea, Research Support, U.S. Gov't, P.H.S, Child Development, Postoperative Complications, Research Support, N.I.H., Extramural, Risk Factors, Journal Article, Humans, Comparative Study, Anesthesia, Wakefulness, General, Anesthesia, General, Anesthesia, Spinal, Female, Follow-Up Studies, Infant, Infant, Newborn, Treatment Outcome, Anesthesiology and Pain Medicine, Research Support, Non-U.S. Gov't, Newborn, Multicenter Study, Randomized Controlled Trial
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.

Published
2015

4. Predictors of Failure of Awake Regional Anesthesia for Neonatal Hernia Repair: Data from the General Anesthesia Compared to Spinal Anesthesia Study-Comparing Apnea and Neurodevelopmental Outcomes

Author

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

Subjects
Male, Hernia, Internationality, Spinal, Apnea, Hernia, Inguinal, Anesthesia, Conduction, Anesthesia, General, Anesthesia, Spinal, Child Development, Cohort Studies, Female, Humans, Infant, Infant, Newborn, Predictive Value of Tests, Prospective Studies, Single-Blind Method, Treatment Failure, Treatment Outcome, Anesthesiology and Pain Medicine, Conduction, Article, Anesthesia, General, Newborn, Inguinal
Abstract

Awake regional anesthesia (RA) is a viable alternative to general anesthesia (GA) for infants undergoing lower abdominal surgery. Benefits include lower incidence of postoperative apnea and avoidance of anesthetic agents that may increase neuroapoptosis and worsen neurocognitive outcomes. The General Anesthesia compared to Spinal anesthesia study compares neurodevelopmental outcomes after awake RA or GA in otherwise healthy infants. The aim of the study is to describe success and failure rates of RA and report factors associated with failure.This was a nested cohort study within a prospective, randomized, controlled, observer-blind, equivalence trial. Seven hundred twenty-two infants 60 weeks or less postmenstrual age scheduled for herniorrhaphy under anesthesia were randomly assigned to receive RA (spinal, caudal epidural, or combined spinal caudal anesthetic) or GA with sevoflurane. The data of 339 infants, where spinal or combined spinal caudal anesthetic was attempted, were analyzed. Possible predictors of failure were assessed including patient factors, technique, experience of site and anesthetist, and type of local anesthetic.RA was sufficient for the completion of surgery in 83.2% of patients. Spinal anesthesia was successful in 86.9% of cases and combined spinal caudal anesthetic in 76.1%. Thirty-four patients required conversion to GA, and an additional 23 patients (6.8%) required brief sedation. Bloody tap on the first attempt at lumbar puncture was the only risk factor significantly associated with block failure (odds ratio = 2.46).The failure rate of spinal anesthesia was low. Variability in application of combined spinal caudal anesthetic limited attempts to compare the success of this technique to spinal alone.

Published
2015

5. 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

Author

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

Published
2015

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