Javier Barrio1, Carlos L Errando2, Jaime García-Ramón3, Rafael Sellés3, Guillermo San Miguel3, Juan Gallego4. 1. Hospital Arnau de Vilanova de Valencia, C/ San Clement 12, 46015 Valencia, Spain. Electronic address: jbarrio.ma@gmail.com. 2. Consorcio Hospital General Universitario de Valencia, Av. Tres Cruces, 2, 46014 Valencia, Spain. 3. Hospital Arnau de Vilanova de Valencia, C/ San Clement 12, 46015 Valencia, Spain. 4. Department of Surgery, Faculty of Medicine and Odontology, University of Valencia, Avda. Blasco Ibáñez 15, 46010 Valencia, Spain.
Abstract
STUDY OBJECTIVE: To evaluate the influence of neuromuscular blockade (NMB) on surgical conditions during low-pressure pneumoperitoneum (8mmHg) laparoscopic cholecystectomy (LC), while comparing moderate and deep NMB. Secondary objective was to evaluate if surgical conditions during low-pressure pneumoperitoneum LC performed with deep NMB could be comparable to those provided during standard-pressure pneumoperitoneum (12mmHg) LC. DESIGN: Prospective, randomized, blinded clinical trial. SETTING: Operating room. PATIENTS: Ninety ASA 1-2 patients scheduled for elective LC. INTERVENTIONS: Patients were allocated into 3 groups: Group 1: low-pressure pneumoperitoneum with moderate-NMB (1-3 TOF), Group 2: low-pressure pneumoperitoneum with deep-NMB (1-5 PTC) and Group 3: standard pneumoperitoneum (12mmHg). Rocuronium was used to induce NMB and acceleromiography was used for NMB monitoring (TOF-Watch-SX). MEASUREMENTS: Three experienced surgeons evaluated surgical conditions using a four-step scale at three time-points: surgical field exposure, dissection of the gallbladder and extraction/closure. MAIN RESULTS:Low-pressure pneumoperitoneum (Group 1 vs. 2): good conditions: 96.7 vs. 96.7%, 90 vs. 80% and 89.6 vs. 92.3%, respectively for the time-points, p>0.05. No differences in optimal surgical conditions were observed between the groups. Surgery completion at 8mmHg pneumoperitoneum: 96.7 vs. 86.7%, p=0.353. Standard-pressure pneumoperitoneum vs. low-pressure pneumoperitoneum with deep NMB (Group 3 vs. 2): good conditions: 100% in Group 3 for the three time-points (p=0.024 vs. Group 2 at dissection of the gallbladder). Significantly greater percentage of optimal conditions during standard-pressure pneumoperitoneum LC at the three time points of evaluation. CONCLUSIONS: The depth of NMB was found not to be decisive neither in the improvement of surgical conditions nor in the completion of low-pressure pneumoperitoneum LC performed by experienced surgeons. Surgical conditions were considered better with a standard-pressure pneumoperitoneum, regardless of the depth of NMB, than during low-pressure pneumoperitoneum with deep NMB.
RCT Entities:
STUDY OBJECTIVE: To evaluate the influence of neuromuscular blockade (NMB) on surgical conditions during low-pressure pneumoperitoneum (8mmHg) laparoscopic cholecystectomy (LC), while comparing moderate and deep NMB. Secondary objective was to evaluate if surgical conditions during low-pressure pneumoperitoneum LC performed with deep NMB could be comparable to those provided during standard-pressure pneumoperitoneum (12mmHg) LC. DESIGN: Prospective, randomized, blinded clinical trial. SETTING: Operating room. PATIENTS: Ninety ASA 1-2 patients scheduled for elective LC. INTERVENTIONS:Patients were allocated into 3 groups: Group 1: low-pressure pneumoperitoneum with moderate-NMB (1-3 TOF), Group 2: low-pressure pneumoperitoneum with deep-NMB (1-5 PTC) and Group 3: standard pneumoperitoneum (12mmHg). Rocuronium was used to induce NMB and acceleromiography was used for NMB monitoring (TOF-Watch-SX). MEASUREMENTS: Three experienced surgeons evaluated surgical conditions using a four-step scale at three time-points: surgical field exposure, dissection of the gallbladder and extraction/closure. MAIN RESULTS: Low-pressure pneumoperitoneum (Group 1 vs. 2): good conditions: 96.7 vs. 96.7%, 90 vs. 80% and 89.6 vs. 92.3%, respectively for the time-points, p>0.05. No differences in optimal surgical conditions were observed between the groups. Surgery completion at 8mmHg pneumoperitoneum: 96.7 vs. 86.7%, p=0.353. Standard-pressure pneumoperitoneum vs. low-pressure pneumoperitoneum with deep NMB (Group 3 vs. 2): good conditions: 100% in Group 3 for the three time-points (p=0.024 vs. Group 2 at dissection of the gallbladder). Significantly greater percentage of optimal conditions during standard-pressure pneumoperitoneum LC at the three time points of evaluation. CONCLUSIONS: The depth of NMB was found not to be decisive neither in the improvement of surgical conditions nor in the completion of low-pressure pneumoperitoneum LC performed by experienced surgeons. Surgical conditions were considered better with a standard-pressure pneumoperitoneum, regardless of the depth of NMB, than during low-pressure pneumoperitoneum with deep NMB.
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