NCT03144453.
Trial name or title | Recovery from anesthesia after robotic assisted radical cystectomy |
Methods |
Allocation: randomized Intervention model: parallel assignment Masking: participant, care provider, investigator, outcomes assessor Primary purpose: treatment |
Participants |
Estimated enrolment: 50 Inclusion criteria:
Exclusion criteria:
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Interventions |
Control group: Participants received neostigmine + atropine as neuromuscular blockade reversal Interventions group: Participants received sugammadex as neuromuscular blockade reversal |
Outcomes |
Primary outcome measures:
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Starting date | 2 May 2017 |
Contact information | Ester Forastierem Rome, Italy Contact: Ester Forastiere: ester.forastiere@ifo.gov.it Regina Elena Cancer Institute, Rome,Italy Contact: Forastiere Ester: forastiere@ifo.it Sub‐Investigator: Claudia Claroni |
Notes | Currently recruiting participants. Estimated Study Completion Date: November 2017 |
List of acronyms and abbreviations used in these tables
ASA ‐ American Society of Anesthesiology; BMI ‐ body mass index; CI ‐ confidence interval; CNS ‐ central nervous system; COPD ‐ chronic obstructive pulmonary disease; CrCL ‐ creatinine clearance; DEF – dynamic end‐tidal forcing; DL – diffusion lung capacity; DLCO/VA – diffusion lung capacity for carbon monoxide/alveolar volume ratio; dNMB – deep neuromuscular blockage; eGFR ‐ estimated glomerular filtration rate;
ENT – ear, nose, and throat; FEV1 – forced expiratory volume in one second; FiO2 ‐ fraction of inspired oxygen; FVC – functional vital capacity; GCS – Glasgow Coma Scale; GOLD – Global initiative for Chronic Obstructive Lung Disease; Hb ‐ haemoglobin; IU/L – international unit/litre; ICU ‐ intensive care unit; IU/L ‐ international units/litre; IV ‐ intravenous; MedDRA ‐ Medical Dictionary for Regulatory Activities; MELD ‐ model for end‐stage liver disease; METS ‐ metabolic equivalent of tasks; NMB ‐ neuromuscular blocking; NMBA ‐ neuromuscular blocking agent; NSQIP ‐ national surgical quality improvement program; OR ‐ operations room; PaCO2 ‐ partial pressure of carbon dioxide; PACU ‐ post anaesthesia care unit; PADSS ‐ post anaesthesia discharge score system; PaO2 ‐ partial pressure of oxygen in blood; PEF ‐ peak expiratory flow; pO2 ‐ partial pressure of oxygen; PONV ‐ postoperative nausea and vomiting; PTC ‐ post‐tetanic count; PQRS ‐ postoperative quality recovery scale; SpO2 ‐ peripheral oxygen saturation; Sq ‐ square; SRS ‐ surgical rating score; TOF ‐ train of four; TOFR ‐ train‐of‐four ratio; VA ‐ alveolar volume; VAS ‐ visual analogue scale