INTRODUCTION:Laparoscopic cholecystectomy (LC) can be performed using low intra-abdominal pressure (< 12 mmHg), but surgical conditions may not be optimal. The present study aimed at comparing surgical space conditions using either deep, continuous muscle relaxation or moderate blockade during low-pressure (8 mmHg) LC. We hypothesized that a deep neuromuscular block would be associated with a higher proportion of optimal surgical space conditions. MATERIAL AND METHODS: This was an investigator-initiated, patient- and assessor-blinded study. Up to 72 patients scheduled for elective LC were randomised to either deep neuromuscular blockade (post-tetanic count 0-1) or moderate neuromuscular blockade, where at least one response to train-of-four nerve stimulation was present. The primary outcome was surgical space conditions at the time during surgery when conditions were worst. The secondary outcomes included the proportion of procedures completed at pneumoperitoneum 8mmHg, post-operative pain, and incidence of nausea and vomiting. RESULTS: This study was the first randomised study to assess the association between depth of neuromuscular blockade and surgical space conditions during low-pressure LC. The study findings may be applicable to a general surgical population undergoing LC. FUNDING: The University of Copenhagen, Denmark and Sophus Johansens Foundation of 1981, Denmark funded this study, which was also financed by a research grant from the Investigator Initiated Studies Program of Merck Sharp and Dohme Corp. TRIAL REGISTRATION: NCT 01523886.
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INTRODUCTION: Laparoscopic cholecystectomy (LC) can be performed using low intra-abdominal pressure (< 12 mmHg), but surgical conditions may not be optimal. The present study aimed at comparing surgical space conditions using either deep, continuous muscle relaxation or moderate blockade during low-pressure (8 mmHg) LC. We hypothesized that a deep neuromuscular block would be associated with a higher proportion of optimal surgical space conditions. MATERIAL AND METHODS: This was an investigator-initiated, patient- and assessor-blinded study. Up to 72 patients scheduled for elective LC were randomised to either deep neuromuscular blockade (post-tetanic count 0-1) or moderate neuromuscular blockade, where at least one response to train-of-four nerve stimulation was present. The primary outcome was surgical space conditions at the time during surgery when conditions were worst. The secondary outcomes included the proportion of procedures completed at pneumoperitoneum 8 mmHg, post-operative pain, and incidence of nausea and vomiting. RESULTS: This study was the first randomised study to assess the association between depth of neuromuscular blockade and surgical space conditions during low-pressure LC. The study findings may be applicable to a general surgical population undergoing LC. FUNDING: The University of Copenhagen, Denmark and Sophus Johansens Foundation of 1981, Denmark funded this study, which was also financed by a research grant from the Investigator Initiated Studies Program of Merck Sharp and Dohme Corp. TRIAL REGISTRATION: NCT 01523886.
Authors: John Vlot; Patricia A Specht; René M H Wijnen; Joost van Rosmalen; Egbert G Mik; Klaas M A Bax Journal: Surg Endosc Date: 2014-11-01 Impact factor: 4.584
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Authors: Denise P Veelo; Suzanne S Gisbertz; Rebekka A Hannivoort; Susan van Dieren; Bart F Geerts; Mark I van Berge Henegouwen; Markus W Hollmann Journal: Trials Date: 2015-08-05 Impact factor: 2.279