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. 2017 Aug 14;2017(8):CD012763. doi: 10.1002/14651858.CD012763

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:
  • ≥ 18 years of age

  • ASA score ≤ III

  • Underwent robotic assisted cystectomy


Exclusion criteria:
  • Cerebrovascular disease

  • BMI (body mass index) ≥ 30

Interventions Control group:
Participants received neostigmine + atropine as neuromuscular blockade reversal
Interventions group:
Participants received sugammadex as neuromuscular blockade reversal
Outcomes Primary outcome measures:
  • Time to discharge from recovery room [Time Frame: up to 240 minutes after recovery]

  • Time between reversal administration and discharge from recovery room

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