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

NCT02454504.

Trial name or title Quality of awakening and impact on cognitive function after administration of sugammadex in robotic radical cystectomy
Methods Allocation: randomized
Intervention model: parallel assignment
Masking: open‐label
Participants Estimated enrolment: 60
Inclusion criteria:
  • ASA score ≤ III

  • Underwent robotic cystectomy


Exclusion criteria:
  • Cerebrovascular disease

  • BMI ≥ 30

Interventions Sugammadex at completion of surgery
Neostigmine at completion of surgery
Outcomes Primary outcome measures:
  • Average score obtained on awakening according to specific test [Time Frame: 16 months] [Designated as safety issue: yes] Cognitive function as assessed by the Mini‐Mental State Exam; quality of awakening as assessed by the Observer's Assessment of Alertness/Sedation

Starting date March 2014
Contact information Ester Forastiere, Dr, 0039 06 52662995: forastiere@ifo.it
Regina Elena Cancer Institute
Rome, RM, Italy, 00144
Sub‐Investigator: Claudia Claroni, MD
Notes This study is currently recruiting participants. Estimated Primary Completion Date: December 2016