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

Study Overview
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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.

Official Title
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Fine Tuning of Deep Neuro-muscular Blockade in Robot-assisted Urological Surgery: A Prospective Proof of Concept Investigation

Conditions
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Maintenance of Deep NM Block Without Overdosing

Intervention / Treatment
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* Procedure: Assessment of NM block


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational study group<br>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<br>* Observation of resulting course of NM block under teratment and monitoring as described.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuromuscular block, robot-assisted prostatectomy