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Quality of Awakening and Impact on Cognitive Function After Administration of Sugammadex in Robotic Radical Cystectomy

Not Applicable
Completed
Conditions
Anesthesiology Management
Interventions
Registration Number
NCT02454504
Lead Sponsor
Regina Elena Cancer Institute
Brief Summary

With the aim of enhancing the quality of surgery, the robotic cystectomy is often conducted using continuous intravenous infusion of curare, which ensures maximum neuromuscular relaxation until the end of the intervention. Sugammadex, administered for the reversal of deep neuromuscular blocked, enable rapid awakening. Moreover, Sugammadex seems to have a positive effect also on the recovery of cognitive function, psychomotor coordination and mental ability, effects undocumented in Literature.

The aim of the investigators study was to assess whether the reversal with sugammadex after intraoperative continuous infusion of rocuronium, can improve the quality of awakening.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
Inclusion Criteria
  • ASA score ≤ III
  • Patients underwent robotic cystectomy
Exclusion Criteria
  • Cerebrovascular disease
  • BMI ≥ 30

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
sugammadexsugammadexthis arm will receive sugammadex at the end of the surgery
neostigmineNeostigminethis arm will receive neostigmine at the end of the surgery
Primary Outcome Measures
NameTimeMethod
average score obtained on awakening according to specific test16 months

cognitive function as assessed by the Mini Mental State Exam; quality of awakening as assessed by the Observer's Assessment of Alterness/sedation

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Regina Elena Cancer Institute

🇮🇹

Rome, RM, Italy

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