Neuromuscular BlockadeCaliRevNCT03649672
The Validity and Tolerability of Awake Calibration of the TOF Watch SX Monitor
A study testing TOF Watch SX in people with Neuromuscular Blockade, run by Christoph Czarnetzki at 2 sites in Switzerland.
Trial summary
Neuromuscular blocking agents (NMBAs) are frequently used in anesthesia and quantitative monitoring of neuromuscular block is standard care. Normally the calibration of the neuromuscular monitor is done after anesthesia induction to avoid patient discomfort. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- TOF Watch SX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 26 Oct 2018to 9 Nov 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists class I or II
- patients undergoing elective surgery lasting at least 60 minutes under general anesthesia requiring neuromuscular blockade using rocuronium bromide for endotracheal intubation
Who cannot join
- Patient with a history of allergy or hypersensitivity to rocuronium.
- Patients with neuromuscular disease
- Patients with preoperative medications known to influence neuromuscular function (for instance aminoglycosides, phenytoin, lidocaine)
- Patients with electrolyte abnormalities (for instance, hypermagnesemia)
- Patients with a body mass index <19 or >30 kg m2
- Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial
- Patients undergoing interventions that need a continuous deep neuromuscular block
- Pregnant or breast feeding women
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital of Geneva, Anesthesia Department
Geneva, Canton of Geneva, 1211
Ospedale Regionale di Lugano
Lugano, Canton Ticino, 6900
About this study
Official title: The Validity and Tolerability of Awake Calibration of the TOF Watch SX® Monitor: An Interventional Prospective Single Two-center Study
Neuromuscular blocking agents (NMBAs) are frequently used in anesthesia and quantitative monitoring of neuromuscular block is standard care. Normally the calibration of the neuromuscular monitor is done after anesthesia induction to avoid patient discomfort. Under certain circumstances there is no time for the calibration process. In the so-called rapid sequence induction (RSI) the neuromuscular blocking agent has to be injected immediately after the induction agent. As the neuromuscular monitor cannot be calibrated, precise neuromuscular monitoring is not possible, and this is of particular disadvantage, when high doses of non-depolarizing neuromuscular blockers are injected to fasten the onset of neuromuscular block. The primary objective is to validate the measurements of the TOF Watch SX® monitor calibrated in awake patients by comparing them with the measurements obtained with the TOF Watch SX® monitor calibrated after anesthesia induction (Gold standard).
The secondary objective is to evaluate the tolerability of the awake calibration process of the TOF Watch SX® monitor.
Read the detailed description
Neuromuscular function will be assessed by acceleromyography of the adductor pollicis with a TOF-Watch SX® monitor on both arms. By randomization it will be chosen on which arm the awake calibration will be done. 5 minutes before the awake calibration process the patients will receive 0.2 µg/kg of sufentanil intravenously. Immediately after the end of the calibration process the patients will rate the pain of the calibration process on a visual analog scale from 0 to 10. Anesthesia will then be induced and immediately at loss of consciousness continuous TOF stimulation will be continued every 12s. Then the calibration process on the other arm will be started, followed by continuous TOF stimulation. After having obtained stable baseline measurements with the TOF-Watch SX® monitor, a bolus dose of rocuronium 0.6 mg kg-1 will be administered intravenously. The trachea will be intubated when full neuromuscular block is reached. No additional rocuronium will be given. Both neuromuscular monitors will be linked via a fiber-optic (TOF-Link®) cable with UBS port to a laptop. Specific software will be used to record the measurements (TOF watch SX® monitor, version 2.2). Neuromuscular monitoring will be continued until a normalized TOF ratio of 0.9 has been obtained on both arms. The onset of neuromuscular block and its spontaneous recovery will be recorded and the results obtained on each arm will be compared. Every patient is his own control.
- Conditions
- Neuromuscular Blockade
- Being tested
- TOF Watch SX
- Keywords
- Tof Watch, rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF Watch SXDevice
Neuromuscular monitoring via the TOF Watch SX device
| Study group | Role | What they receive |
|---|---|---|
| Awake calibration | Experimental | The dominant arm of the patient Receives: Device: TOF Watch SX |
| Asleep calibration | Active comparator | The non dominant arm of the patient Receives: Device: TOF Watch SX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery time
Total duration of the neuromuscular block defined as the time in minutes from start of injection of rocuronium until a normalized TOF ratio of 90%
Measured: during the duration of the general anesthesia
Secondary outcomes (6)
Onset time
The time in seconds from start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF
Measured: during the duration of the general anesthesia
Dur TOFc1
Time in minutes from administration of rocuronium to emergence of the 1st twitch of the TOF
Measured: during the duration of the general anesthesia
Dur TOF 25%
Time in minutes from administration of rocuronium to emergence of a TOF ratio of 25%
Measured: during the duration of the general anesthesia
Dur TOF 50%
Time in minutes from administration of rocuronium to emergence of a TOF ratio of 50%
Measured: during the duration of the general anesthesia
Dur TOF 75%
Time in minutes from administration of rocuronium to emergence of a TOF ratio of 75%
Measured: during the duration of the general anesthesia
TOF pain: VAS
The pain experienced during the calibration process evaluated by a visual analogue scale from 0 to 10.
Measured: before inductin of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start26 Oct 2018
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Why it stopped: Due to Covid Crisis recruitment was stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Neuromuscular monitoring by TOF Watch SX on the dominant and on the non dominant arm
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph Czarnetzki
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital du Valais
- Responsible party
- Sponsor-investigator, Christoph Czarnetzki, University Hospital, Geneva
- Investigators
- Christoph A Czarnetzki, MD, Study chair, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649672
- Sponsor's protocol ID
- CaliRev
- Acronym
- CaliRev
- Status last verified
- Jan 2022
- First submitted
- 24 Aug 2018
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Tolerability of Awake Calibration of the TOF Watch SX® Monitor: An Interventional Prospective Single Two-center Study
- ClinicalTrials.gov ID
- NCT03649672
- Acronym / sponsor ID
- CaliRev / CaliRev
- Conditions
- Neuromuscular Blockade
- Keywords
- Tof Watch, rocuronium
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Covid Crisis recruitment was stopped.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Christoph CzarnetzkiUniversity, hospital or other
- Collaborators
- Hôpital du Valais
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 28 Aug 2018 (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.
Neuromuscular blocking agents (NMBAs) are frequently used in anesthesia and quantitative monitoring of neuromuscular block is standard care. Normally the calibration of the neuromuscular monitor is done after anesthesia induction to avoid patient discomfort. Under certain circumstances there is no time for the calibration process. In the so-called rapid sequence induction (RSI) the neuromuscular blocking agent has to be injected immediately after the induction agent. As the neuromuscular monitor cannot be calibrated, precise neuromuscular monitoring is not possible, and this is of particular disadvantage, when high doses of non-depolarizing neuromuscular blockers are injected to fasten the onset of neuromuscular block. The primary objective is to validate the measurements of the TOF Watch SX® monitor calibrated in awake patients by comparing them with the measurements obtained with the TOF Watch SX® monitor calibrated after anesthesia induction (Gold standard).
The secondary objective is to evaluate the tolerability of the awake calibration process of the TOF Watch SX® monitor.
Detailed description
Neuromuscular function will be assessed by acceleromyography of the adductor pollicis with a TOF-Watch SX® monitor on both arms. By randomization it will be chosen on which arm the awake calibration will be done. 5 minutes before the awake calibration process the patients will receive 0.2 µg/kg of sufentanil intravenously. Immediately after the end of the calibration process the patients will rate the pain of the calibration process on a visual analog scale from 0 to 10. Anesthesia will then be induced and immediately at loss of consciousness continuous TOF stimulation will be continued every 12s. Then the calibration process on the other arm will be started, followed by continuous TOF stimulation. After having obtained stable baseline measurements with the TOF-Watch SX® monitor, a bolus dose of rocuronium 0.6 mg kg-1 will be administered intravenously. The trachea will be intubated when full neuromuscular block is reached. No additional rocuronium will be given. Both neuromuscular monitors will be linked via a fiber-optic (TOF-Link®) cable with UBS port to a laptop. Specific software will be used to record the measurements (TOF watch SX® monitor, version 2.2). Neuromuscular monitoring will be continued until a normalized TOF ratio of 0.9 has been obtained on both arms. The onset of neuromuscular block and its spontaneous recovery will be recorded and the results obtained on each arm will be compared. Every patient is his own control.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Neuromuscular monitoring by TOF Watch SX on the dominant and on the non dominant arm
| Arm | Type | Receives |
|---|---|---|
| Awake calibration | Experimental | Device: TOF Watch SXThe dominant arm of the patient |
| Asleep calibration | Active comparator | Device: TOF Watch SXThe non dominant arm of the patient |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists class I or II
- patients undergoing elective surgery lasting at least 60 minutes under general anesthesia requiring neuromuscular blockade using rocuronium bromide for endotracheal intubation
Key exclusion criteria (8 listed)
- Patient with a history of allergy or hypersensitivity to rocuronium.
- Patients with neuromuscular disease
- Patients with preoperative medications known to influence neuromuscular function (for instance aminoglycosides, phenytoin, lidocaine)
- Patients with electrolyte abnormalities (for instance, hypermagnesemia)
- Patients with a body mass index <19 or >30 kg m2
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 |
|---|---|---|
| TOF Watch SXNeuromuscular monitoring via the TOF Watch SX device | Device | Asleep calibration, Awake calibration |
Primary outcome
Total recovery time
Time frame: during the duration of the general anesthesia
Total duration of the neuromuscular block defined as the time in minutes from start of injection of rocuronium until a normalized TOF ratio of 90%
6 secondary outcomes
Onset time
Time frame: during the duration of the general anesthesia
Dur TOFc1
Time frame: during the duration of the general anesthesia
Dur TOF 25%
Time frame: during the duration of the general anesthesia
Dur TOF 50%
Time frame: during the duration of the general anesthesia
Dur TOF 75%
Time frame: during the duration of the general anesthesia
TOF pain: VAS
Time frame: before inductin of general anesthesia
Results and safety
The study was stopped early (reason given: Due to Covid Crisis recruitment was stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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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.
Christoph A Czarnetzki, MD study chair
University Hospital, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOF Watch SX in people with Neuromuscular Blockade, run by Christoph Czarnetzki at 2 sites 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Due to Covid Crisis recruitment was stopped.). Results are not available in the source record.
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?
Total recovery time (time frame: during the duration of the general anesthesia). 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 21 Jan 2022.