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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02454504
Enrollment
120
Registered
2015-05-27
Start date
2015-03-31
Completion date
2016-08-31
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesiology Management

Keywords

Sugammadex, Delayed Emergence from Anesthesia, Curare, Robotic Surgical Procedures

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.

Interventions

DRUGsugammadex
DRUGNeostigmine

Sponsors

Regina Elena Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ASA score ≤ III * Patients underwent robotic cystectomy

Exclusion criteria

* Cerebrovascular disease * BMI ≥ 30

Design outcomes

Primary

MeasureTime frameDescription
average score obtained on awakening according to specific test16 monthscognitive function as assessed by the Mini Mental State Exam; quality of awakening as assessed by the Observer's Assessment of Alterness/sedation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026