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Recovery From Anesthesia After Robotic Assisted Radical Cystectomy

R

Regina Elena Cancer Institute

Status and phase

Unknown
Phase 4

Conditions

Anesthesiology Management

Treatments

Drug: Neostigmine, Atropine
Drug: Sugammadex Injectable Product

Study type

Interventional

Funder types

Other

Identifiers

NCT03144453
CE/2288

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups

Sugammadex
Experimental group
Description:
The patients received sugammadex as neuromuscular blockade reversal
Treatment:
Drug: Sugammadex Injectable Product
Standard
Active Comparator group
Description:
The patients received neostigmine + atropine as neuromuscular blockade reversal
Treatment:
Drug: Neostigmine, Atropine

Trial contacts and locations

2

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Central trial contact

Ester Forastiere, Chief

Data sourced from clinicaltrials.gov

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