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The Validity and Tolerability of Awake Calibration of the TOF Watch SX Monitor (CaliRev)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649672
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Hôpital du Valais
Information provided by (Responsible Party):
Christoph Czarnetzki, University Hospital, Geneva

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Device: TOF Watch SX Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Neuromuscular monitoring by TOF Watch SX on the dominant and on the non dominant arm
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Validity and Tolerability of Awake Calibration of the TOF Watch SX® Monitor: An Interventional Prospective Single Two-center Study
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Awake calibration
The dominant arm of the patient
Device: TOF Watch SX
Neuromuscular monitoring via the TOF Watch SX device

Active Comparator: Asleep calibration
The non dominant arm of the patient
Device: TOF Watch SX
Neuromuscular monitoring via the TOF Watch SX device




Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. Onset time [ Time Frame: during the duration of the general anesthesia ]
    The time in seconds from start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF

  2. Dur TOFc1 [ Time Frame: during the duration of the general anesthesia ]
    Time in minutes from administration of rocuronium to emergence of the 1st twitch of the TOF

  3. Dur TOF 25% [ Time Frame: during the duration of the general anesthesia ]
    Time in minutes from administration of rocuronium to emergence of a TOF ratio of 25%

  4. Dur TOF 50% [ Time Frame: during the duration of the general anesthesia ]
    Time in minutes from administration of rocuronium to emergence of a TOF ratio of 50%

  5. Dur TOF 75% [ Time Frame: during the duration of the general anesthesia ]
    Time in minutes from administration of rocuronium to emergence of a TOF ratio of 75%

  6. TOF pain: VAS [ Time Frame: before inductin of general anesthesia ]
    The pain experienced during the calibration process evaluated by a visual analogue scale from 0 to 10.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649672


Contacts
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Contact: Christoph A Czarnetzki, MD +41 079 55 32 113 christoph.czarnetzki@hcuge.ch
Contact: Sina Grape, MD +41 27 603 87 59 sina.grape@hopitalvs.ch

Locations
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Switzerland
University Hospital of Geneva, Anesthesia Department
Geneva, Canton Of Geneva, Switzerland, 1211
Sponsors and Collaborators
Christoph Czarnetzki
Hôpital du Valais
Investigators
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Study Chair: Christoph A Czarnetzki, MD University Hospital, Geneva

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Responsible Party: Christoph Czarnetzki, MD, MBA, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03649672    
Other Study ID Numbers: CaliRev
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Christoph Czarnetzki, University Hospital, Geneva:
Tof Watch, rocuronium