Neuromuscular Blockade
Conditions
Keywords
Tof Watch, rocuronium
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.
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.
Interventions
DEVICETOF Watch SX
Neuromuscular monitoring via the TOF Watch SX device
Sponsors
Hôpital du Valais
Christoph Czarnetzki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Neuromuscular monitoring by TOF Watch SX on the dominant and on the non dominant arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total recovery time | 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
| Measure | Time frame | Description |
|---|---|---|
| Dur TOFc1 | during the duration of the general anesthesia | Time in minutes from administration of rocuronium to emergence of the 1st twitch of the TOF |
| Dur TOF 25% | during the duration of the general anesthesia | Time in minutes from administration of rocuronium to emergence of a TOF ratio of 25% |
| Onset time | 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 |
| Dur TOF 75% | during the duration of the general anesthesia | Time in minutes from administration of rocuronium to emergence of a TOF ratio of 75% |
| TOF pain: VAS | before inductin of general anesthesia | The pain experienced during the calibration process evaluated by a visual analogue scale from 0 to 10. |
| Dur TOF 50% | during the duration of the general anesthesia | Time in minutes from administration of rocuronium to emergence of a TOF ratio of 50% |
Countries
Switzerland
Outcome results
None listed