Recovery From Anesthesia After Robotic Assisted Radical Cystectomy

Anesthesiology Management Clinical Trial

Official title:

Recovery From Anesthesia After Robotic Assisted Radical Cystectomy. Two Different Reversal of Neuromuscular Blockade

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03144453
• Other study ID #: CE/2288
• Status: Recruiting
• Phase: Phase 4
• Start date: May 2, 2017
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Regina Elena Cancer Institute
• Contact: Ester Forastiere, Chief
• Phone: +39 06 52662449
• Email: ester.forastiere[@]ifo.gov.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Robot-assisted radical cystectomy (RARC) requires specific surgical conditions: steep Trendelenburg position, prolonged pneumoperitoneum, effective neuromuscular block until the final stages of surgery. The aim of this study was to evaluate the quality of awakening in two groups of patients undergoing different combinations of curarization/reversal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA (american society of anesthesiologists) score = III

• Patients underwent robotic assisted cystectomy

Exclusion Criteria:

• Cerebrovascular disease

• BMI (body mass index) = 30

Related Conditions & MeSH terms

• Anesthesiology Management

Intervention

Drug:
• Sugammadex Injectable Product
Patients receive sugammadex at the end of the surgery
• Neostigmine, Atropine
Patients receive neostigmine+atropine at the end of the surgery

Locations

Country	Name	City	State
Italy	Ester Forastiere	Rome	RM
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	Time to discharge from recovery room	Time between reversal administration and discharge from the recovery room	Up to 240 Minutes After recovery