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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2016

Interventions

  • Drug: sugammadex
  • Drug: Neostigmine

Arms, Groups and Cohorts

  • Active Comparator: sugammadex
    • this arm will receive sugammadex at the end of the surgery
  • Active Comparator: neostigmine
    • this arm will receive neostigmine at the end of the surgery

Clinical Trial Outcome Measures

Primary Measures

  • average score obtained on awakening according to specific test
    • Time Frame: 16 months
    • cognitive function as assessed by the Mini Mental State Exam; quality of awakening as assessed by the Observer’s Assessment of Alterness/sedation

Participating in This Clinical Trial

Inclusion Criteria

  • ASA score ≤ III – Patients underwent robotic cystectomy Exclusion Criteria:

  • Cerebrovascular disease – BMI ≥ 30

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regina Elena Cancer Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ester Forastiere, Dr – Regina Elena Cancer Institute

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