Recovery From Anesthesia After Robotic Assisted Radical C... | NCT03144453

Studies
Recovery From Anesthesia After Robotic Assisted Radical Cystectomy

NCT03144453

Sponsor

Regina Elena Cancer Institute

Status

Unknown status

Last Update Posted

Jan 28, 2019Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Anesthesiology Management

Interventions

Sugammadex Injectable Product
Neostigmine, Atropine

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2017Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

May 3, 2017

First Submission Date that Met QC Criteria

May 5, 2017

First Posted Date

May 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2019

Last Update Posted Date

Jan 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sugammadex Injectable Product	Drug	Patients receive sugammadex at the end of the surgery	Sugammadex

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Cerebrovascular disease
BMI (body mass index) ≥ 30

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ester Forastiere, Chief	Contact	+39 06 52662449		ester.forastiere@ifo.gov.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ester Forastiere	Recruiting	Rome	RM	00144	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D009388	Neostigmine
D001285	Atropine

Ancestor Terms

ID	Term
D050338	Phenylammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided