Fine Tuning of Neuro-muscular Blockade in Robot-assisted... | NCT04638907

Studies
Fine Tuning of Neuro-muscular Blockade in Robot-assisted Prostatectomy

NCT04638907

Sponsor

Peter Biro

Status

Completed

Last Update Posted

Nov 20, 2020Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Maintenance of Deep NM Block Without Overdosing

Interventions

Assessment of NM block

Countries

Switzerland

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2017Actual

Primary Completion Date

Jul 15, 2019Actual

Completion Date

Dec 15, 2019Actual

First Submitted Date

Nov 16, 2020

First Submission Date that Met QC Criteria

Nov 19, 2020

First Posted Date

Nov 20, 2020Actual

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

Nov 19, 2020

Last Update Posted Date

Nov 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Assessing the routinely used protokoll for deep NM Block during robot-assisted prostatectomy in general anesthesia. The protocoll contains the repeated dosing of rocuronium according to the results of relaxometry performed with a TOFcuff relaxometer (RGB Medical, Madrid) during pneumoperitoneum. This is done by keeping the block level between 1 to 6 PTC (post tetanic counts). The scope of the study was to find out, to which percentage this protocoll permits the maintenance of block level inside of the desired range.

Detailed Description

Robot-assisted urological interventions require sufficiently deep neuromuscular relaxation (NMR) during the phase of pneumoperitoneum. This is achieved by repeated administration of the non-depolarizing neuromuscular relaxant rocuronium, which is used in clinical routine. The level of relaxation is usually measured with the TOF-Watch relaxometer. This device has limitations in its usability and accuracy in this setting because it is unreliable when the monitored arm of the patient is not accessible for the anaesthetist for visual or tactile assessment of finger movements. The novel TOF-Cuff relaxometry equipment is by design intended to provide constant and reliable quantitative and in vivo calibrated relaxometric values independently of the arm position. The combination of frequently adjusted neuromuscular relaxation in a standardised mode in combination with a reliable relaxometry by TOFcuff promises an improved surveillance of neuromuscular relaxation and a higher safety standard. This investigation aims to test and to define the combined use of the best available drug with the best available relaxometer for general anesthesia in robot-assisted urological surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational study group		Consenting adult male patients undergoing elective robot-assisted prostatectomy. No further selection or randomisation. Enrollment as availability for the study.	Procedure: Assessment of NM block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assessment of NM block	Procedure	Observation of resulting course of NM block under teratment and monitoring as described.	Observational study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful deep NM block	Time percentage of optimal NM block during pneumoperitoneum	Entire duration of pneumoperitoneum varying between 2 and 5 hours.

Secondary Outcomes

Measure	Description	Time Frame
Surgeon's satisfaction	Overall subjective satisfaction with the patient's relaxation by the surgeon on a verbal rating scale (1 = extremely bad; 10 = excellent)(Staehr-Rye 2014)	Duration of pneumoperitoneum

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

consenting male adults undergoing elective robot-assisted urological surgery.

Exclusion Criteria:

Emergency cases, Patients who don't understand the requirements of the study and don't agree to sign the informed consent. Contraindication to neuromuscular relaxation with rocuronium.

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only men have prostatectomy.

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Unselected pateints, who fulfil the inclusion criteria as they become available for anesthesia and surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donat R Spahn, Prof. Dr.	Institute of Anesthesiology, University Hospital Zurich	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Institue of Anesthesiology		Zurich	Canton of Zurich	8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share the obtained data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided