NCT03144453

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2017

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

2.6 years

First QC Date

May 3, 2017

Last Update Submit

January 25, 2019

Conditions

Anesthesiology Management

Keywords

CurareRobotic surgery

Outcome Measures

Primary Outcomes (1)

  • Time to discharge from recovery room

    Time between reversal administration and discharge from the recovery room

    Up to 240 Minutes After recovery

Study Arms (2)

Sugammadex

EXPERIMENTAL

The patients received sugammadex as neuromuscular blockade reversal

Drug: Sugammadex Injectable Product

Standard

ACTIVE COMPARATOR

The patients received neostigmine + atropine as neuromuscular blockade reversal

Drug: Neostigmine, Atropine

Interventions

Sugammadex Injectable ProductDRUG

Patients receive sugammadex at the end of the surgery

Sugammadex
Neostigmine, AtropineDRUG

Patients receive neostigmine+atropine at the end of the surgery

Standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ester Forastiere

Rome, RM, 00144, Italy

RECRUITING

Regina Elena Cancer Institute

Rome, RM, 00144, Italy

RECRUITING

MeSH Terms

Interventions

NeostigmineAtropine

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Central Study Contacts

Ester Forastiere, Chief

CONTACT

+39 06 52662449ester.forastiere@ifo.gov.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 8, 2017

Study Start

May 2, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 28, 2019

Record last verified: 2019-01

Locations

IT(2)