Clinical trial NCT04638907: Fine Tuning of Neuro-muscular Blockade in Robot-assisted Prostatectomy
Official title: Fine Tuning of Deep Neuro-muscular Blockade in Robot-assisted Urological Surgery: A Prospective Proof of Concept Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maintenance of Deep NM Block Without Overdosing
Keywords: neuromuscular block, robot-assisted prostatectomy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unselected pateints, who fulfil the inclusion criteria as they become available for anesthesia and surgery.

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.

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.

Primary outcomes:
measure: Successful deep NM block
timeFrame: Entire duration of pneumoperitoneum varying between 2 and 5 hours.
Secondary outcomes:
measure: Surgeon's satisfaction
timeFrame: Duration of pneumoperitoneum
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institue of Anesthesiology
state: ZH
Study officials:
affiliation: Institute of Anesthesiology, University Hospital Zurich
name: Donat R Spahn, Prof. Dr.
role: STUDY_CHAIR
References: