Maintenance of Deep NM Block Without OverdosingNMBUroNCT04638907
Fine Tuning of Neuro-muscular Blockade in Robot-assisted Prostatectomy
An observational study of Maintenance of Deep NM Block Without Overdosing, run by Peter Biro at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Maintenance of Deep NM Block Without Overdosing
- What is being tested?
- Assessment of NM block
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jan 2017to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Adult, Older adult
Study population: Unselected pateints, who fulfil the inclusion criteria as they become available for anesthesia and surgery.
Who may be able to join
- consenting male adults undergoing elective robot-assisted urological surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Institue of Anesthesiology
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
Read the 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.
- Being tested
- Assessment of NM block
- Keywords
- neuromuscular block, robot-assisted prostatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of NM blockProcedure or surgery
Observation of resulting course of NM block under teratment and monitoring as described.
| Study group | Role | What they receive |
|---|---|---|
| Observational study group | Consenting adult male patients undergoing elective robot-assisted prostatectomy. No further selection or randomisation. Enrollment as availability for the study. Receives: Procedure: Assessment of NM block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful deep NM block
Time percentage of optimal NM block during pneumoperitoneum
Measured: Entire duration of pneumoperitoneum varying between 2 and 5 hours.
Secondary outcomes (1)
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)
Measured: Duration of pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start15 Jan 2017
- Primary completion15 Jul 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maintenance of Deep NM Block Without OverdosingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Biro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Biro, University of Zurich
- Investigators
- Donat R Spahn, Prof. Dr., Study chair, Institute of Anesthesiology, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638907
- Sponsor's protocol ID
- BASEC ID 2016-01781
- Acronym
- NMBUro
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share the obtained data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fine Tuning of Deep Neuro-muscular Blockade in Robot-assisted Urological Surgery: A Prospective Proof of Concept Investigation
- ClinicalTrials.gov ID
- NCT04638907
- Acronym / sponsor ID
- NMBUro / BASEC ID 2016-01781
- Keywords
- neuromuscular block, robot-assisted prostatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Peter BiroUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational study group | – | Procedure: Assessment of NM blockConsenting adult male patients undergoing elective robot-assisted prostatectomy. No further selection or randomisation. Enrollment as availability for the study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Unselected pateints, who fulfil the inclusion criteria as they become available for anesthesia and surgery.
Key inclusion criteria (1 listed)
- consenting male adults undergoing elective robot-assisted urological surgery.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of NM blockObservation of resulting course of NM block under teratment and monitoring as described. | Procedure or surgery | Observational study group |
Primary outcome
Successful deep NM block
Time frame: Entire duration of pneumoperitoneum varying between 2 and 5 hours.
Time percentage of optimal NM block during pneumoperitoneum
1 secondary outcome
Surgeon's satisfaction
Time frame: Duration of pneumoperitoneum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: No. No plan to share the obtained data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donat R Spahn, Prof. Dr. study chair
Institute of Anesthesiology, University Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maintenance of Deep NM Block Without Overdosing, run by Peter Biro at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful deep NM block (time frame: Entire duration of pneumoperitoneum varying between 2 and 5 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.