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Completed

NCT Number: NCT02454504

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

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.

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Key information

Conditions

Anesthesiology Management Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regina Elena Cancer Institute

Rome, RM, 00144, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA score ≤ III
  • Patients underwent robotic cystectomy

Exclusion criteria

  • Cerebrovascular disease
  • BMI ≥ 30

Treatment and study plan

Sugammadex

Drug

Neostigmine

Drug

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 27, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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