NCT02454504

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

May 6, 2015

Last Update Submit

August 29, 2018

Conditions

Anesthesiology Management

Keywords

SugammadexDelayed Emergence from AnesthesiaCurareRobotic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

sugammadex

ACTIVE COMPARATOR

this arm will receive sugammadex at the end of the surgery

Drug: sugammadex

neostigmine

ACTIVE COMPARATOR

this arm will receive neostigmine at the end of the surgery

Drug: Neostigmine

Interventions

sugammadexDRUG
sugammadex
NeostigmineDRUG
neostigmine

Eligibility Criteria

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

You may qualify if:

  • ASA score ≤ III
  • Patients underwent robotic cystectomy

You may not qualify if:

  • Cerebrovascular disease
  • BMI ≥ 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina Elena Cancer Institute

Rome, RM, 00144, Italy

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

SugammadexNeostigmine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesPhenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 27, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

IT(1)