Fine Tuning of Neuro-muscular Blockade in Robot-assisted Prostatectomy (NMBUro)

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

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.

Study Overview

• Status: Completed
• Conditions: Maintenance of Deep NM Block Without Overdosing
• Intervention / Treatment: Procedure: Assessment of NM block

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Institue of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Unselected pateints, who fulfil the inclusion criteria as they become available for anesthesia and surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational study group; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peter Biro
• Investigators: Study Chair: Donat R Spahn, Prof. Dr., Institute of Anesthesiology, University Hospital Zurich

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): July 15, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: neuromuscular block, robot-assisted prostatectomy
• Other Study ID Numbers: BASEC ID 2016-01781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share the obtained data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No