Recovery From Anesthesia After Robotic Assisted Radical Cystectomy

NCT ID: NCT03144453

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesiology Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sugammadex

The patients received sugammadex as neuromuscular blockade reversal

Group Type EXPERIMENTAL

Sugammadex Injectable Product

Intervention Type DRUG

Patients receive sugammadex at the end of the surgery

Standard

The patients received neostigmine + atropine as neuromuscular blockade reversal

Group Type ACTIVE_COMPARATOR

Neostigmine, Atropine

Intervention Type DRUG

Patients receive neostigmine+atropine at the end of the surgery

Interventions

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Sugammadex Injectable Product

Patients receive sugammadex at the end of the surgery

Intervention Type DRUG

Neostigmine, Atropine

Patients receive neostigmine+atropine at the end of the surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Cerebrovascular disease
* BMI (body mass index) ≥ 30
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Ester Forastiere

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ester Forastiere

Rome, RM, Italy

Site Status RECRUITING

Regina Elena Cancer Institute

Rome, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Ester Forastiere, Chief

Role: CONTACT

+39 06 52662449

Facility Contacts

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Ester Forastiere, Chief

Role: primary

00390652662994

Forastiere Ester

Role: primary

00390652662994

Other Identifiers

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CE/2288

Identifier Type: -

Identifier Source: org_study_id

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