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

Anesthesiology Management Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454504
• Other study ID #: 307.CI
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2018
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA score = III

• Patients underwent robotic cystectomy

Exclusion Criteria:

• Cerebrovascular disease

• BMI = 30

Related Conditions & MeSH terms

• Anesthesiology Management

Intervention

Drug:
• sugammadex

• Neostigmine

Locations

Country	Name	City	State
Italy	Regina Elena Cancer Institute	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average score obtained on awakening according to specific test	cognitive function as assessed by the Mini Mental State Exam; quality of awakening as assessed by the Observer's Assessment of Alterness/sedation	16 months