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OpenTrials
Completed

NCT Number: NCT04638907

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

University Hospital Zurich, Institue of Anesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessment of NM block

Procedure

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

Primary outcomes

  1. Successful deep NM block

    Time frame: Entire duration of pneumoperitoneum varying between 2 and 5 hours.

    Time percentage of optimal NM block during pneumoperitoneum

Secondary outcomes

  1. Surgeon's satisfaction

    Time frame: Duration of pneumoperitoneum

    Overall subjective satisfaction with the patient's relaxation by the surgeon on a verbal rating scale (1 = extremely bad; 10 = excellent)(Staehr-Rye 2014)

Sponsors and collaborators

Lead sponsor

Peter Biro

Other

Registry information

Official study title

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

Acronym: NMBUro

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2020
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.