An observational study in Maintenance of Deep NM Block Without Overdosing, sponsored by Peter Biro. Completed at 1 site in Switzerland. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-11-20.
Sponsored by Peter Biro · Observational
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.
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.
This is the only study on the registry with Peter Biro as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Unselected pateints, who fulfil the inclusion criteria as they become available for anesthesia and surgery.
Exclusion Criteria:
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
Observation of resulting course of NM block under teratment and monitoring as described.
Successful deep NM block
Time percentage of optimal NM block during pneumoperitoneum
Time frame: Entire duration of pneumoperitoneum varying between 2 and 5 hours.
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)
Time frame: Duration of pneumoperitoneum
Plan to share: No — No plan to share the obtained data.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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