Recovery From Anesthesia After Robotic Assisted Radical Cystectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesiology Management
• Intervention / Treatment: Drug: Sugammadex Injectable Product; Drug: Neostigmine, Atropine

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ester Forastiere, Chief; Phone Number: +39 06 52662449; Email: ester.forastiere@ifo.gov.it

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00144
      • Recruiting
      • Regina Elena Cancer Institute
    • Rome, RM, Italy, 00144
      • Recruiting
      • Ester Forastiere
      • Contact: Ester Forastiere, Chief; Phone Number: 00390652662994; Email: ester.forastiere@ifo.gov.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA (american society of anesthesiologists) score ≤ III
• Patients underwent robotic assisted cystectomy

Exclusion Criteria:

• Cerebrovascular disease
• BMI (body mass index) ≥ 30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugammadex; The patients received sugammadex as neuromuscular blockade reversal	Drug: Sugammadex Injectable Product; Patients receive sugammadex at the end of the surgery
Active Comparator: Standard; The patients received neostigmine + atropine as neuromuscular blockade reversal	Drug: Neostigmine, Atropine; Patients receive neostigmine+atropine at the end of the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discharge from recovery room	Time between reversal administration and discharge from the recovery room	Up to 240 Minutes After recovery

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Robotic surgery; Curare
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Cholinesterase Inhibitors; Mydriatics; Parasympathomimetics; Atropine; Neostigmine
• Other Study ID Numbers: CE/2288

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes