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

Maintenance of Deep NM Block Without Overdosing Clinical Trial

— NMBUro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638907
• Other study ID #: BASEC ID 2016-01781
• Status: Completed
• Start date: January 15, 2017
• Est. completion date: December 15, 2019

Study information

• Verified date: November 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 15, 2019
• Est. primary completion date: July 15, 2019
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maintenance of Deep NM Block Without Overdosing

Intervention

Procedure:
• Assessment of NM block
Observation of resulting course of NM block under teratment and monitoring as described.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Institue of Anesthesiology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Peter Biro

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful deep NM block	Time percentage of optimal NM block during pneumoperitoneum	Entire duration of pneumoperitoneum varying between 2 and 5 hours.
Secondary	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