Neuromuscular Blockade Monitoring
Conditions
Brief summary
The staircase phenomenon could have repercussions on the onset and recovery time following administration of a neuromuscular blocking agent. The investigators aim to assess the magnitude of the staircase phenomenon and its impact on various aspects of neuromuscular blockade with a randomized controlled double blind trial.
Interventions
DEVICETetanus stabilization of baseline
Administering a Tetanic stimulus before baseline stabilization shortens the stabilization period of baseline of a neuromuscular block monitor. This acts on the baseline value
Sponsors
Hospital Universitario La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA (American Society of Anesthesiology surgical risk scale) grade I - II * Surgery not involving airway performed under general anaesthesia with neuromuscular blocker
Exclusion criteria
* Pregnancy * BMI (Body Mass Idex) \> 35 Kg/m2 * Anticipated difficult airway * Chronic kidney or hepatic failure * Neuromuscular disease * Medication that has known interactions with neuromuscular blockers * Hemodynamic failure * Anticipated large blood loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Block Onset time difference (seconds) | rom 0 seconds up to 240 seconds after neuromuscular block administration at the beginning of surgery. Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours). | Onset time is the time between Train of Four (TOF) at the moment of injection of neuromuscular blocking drug and the minimum value reached (onset of neuromuscular block) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in TOFr 0.9 Normalized | From administration of neuromuscular blocking drug until spontaneous reversal at this specified point (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours). | Time until recovery of a TOF ratio of 0.9 normalized to baseline TOR ratio after calibration. (e.g. if baseline TOF ratio is 1.1, normalized TOF ratio 0.9 is: 1.1 x 0.9 = 0.99) |
| Difference in time until recovery of 25% of maximum twitch height ot T1 stimulus (DUR25) | From administration of neuromuscular blocking drug until spontaneous reversal at this specified point (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery.(up to 4 hours) | Difference in time until recovery of 25% of maximum twitch height ot T1 stimulus during recovery phase. During recovery phase stimuli begin to recover and their height increases. This outcome is the time between the beginning of neuromuscular block until recovery of 25% of height of the first stimulus of the Train-of-Four.recovery phase. During recovery phase stimuli begin to recover and their height increases. This outcome is the time between the beginning of neuromuscular block until recovery of 25% of height of the first stimulus of the Train-of-Four (TOF) |
| Time between 25% and 75% of maximum twitch height recovery of T1 stimulus | From administration of neuromuscular blocking drug until spontaneous reversal (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours). | Time between 25% and 75% height recovery of maximum twitch height in the recovery phase. |
| Difference between first stimulus of Train-of-Four ratio at baseline | Single measurement of muscle response after calibration procedure at the beginning of data recording after randomization. It is not a time-to-event variable | Difference between T1 at baseline. Train-of-Four ratio is the administration of four consecutive stimuli to the monitored muscle. These stimuli are named T1,T2,T3,T4. This is the difference between tow arms oh T1 height at baseline |
| Difference between T1 height after stabilization period of 20 minutes | Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation. It is not a time-to-event variable | Difference between T1 height after stabilization period of 20 minutes |
| Difference in time until recovery of a TOF ratio (TOFr) of 0.9 | From administration of neuromuscular blocking drug until spontaneous reversal (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours). | Time until recovery of a TOF ratio of 0.9 (reversal of neuromuscular block as assessed by the monitor). During recovery phase stimuli regain height until all four stimuli of the Train-of-Four are present. Train-of-Four ratio is the ratio between the fourth and the first stimuli (T4/T1). |
| Difference between TOF ratio after stabilization period time | Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation. | Difference between TOF ratio after stabilization period time |
| Monitor Sensitivity difference between groups | Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization) | Sensitivity parameter is set by monitor after calibration. |
| Monitor Amperage Intensity after calibration difference (milliAmperes, mA) | Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization) | Monitor Amperage Intensity is set by the monitor after calibration |
| T1/TOFratio relationship difference | Ratio of specified values recorded by the monitor at the beginning of surgery until onset of neuromuscular block (up to 180 seconds) and during spontaneous recovery up to 4 hours until end of anesthesia | During recovery phase T1 over TOF ratio will be calculated and the difference between two groups will be assessed. |
| Difference between TOF ratio at baseline time | Single measurement of muscle response after calibration procedure at the beginning of data recording. | Difference between TOF ratio at baseline time |
Countries
Spain
Outcome results
None listed