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

NCT ID: NCT04638907

Last Updated: 2020-11-20

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

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-15

Study Completion Date

2019-12-15

Brief Summary

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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

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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.

Conditions

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Maintenance of Deep NM Block Without Overdosing

Keywords

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neuromuscular block, robot-assisted prostatectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational study group

Consenting adult male patients undergoing elective robot-assisted prostatectomy. No further selection or randomisation. Enrollment as availability for the study.

Assessment of NM block

Intervention Type PROCEDURE

Observation of resulting course of NM block under teratment and monitoring as described.

Interventions

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Assessment of NM block

Observation of resulting course of NM block under teratment and monitoring as described.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Peter Biro

OTHER

Sponsor Role lead

Responsible Party

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Peter Biro

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Donat R Spahn, Prof. Dr.

Role: STUDY_CHAIR

Institute of Anesthesiology, University Hospital Zurich

Locations

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University Hospital Zurich, Institue of Anesthesiology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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BASEC ID 2016-01781

Identifier Type: -

Identifier Source: org_study_id