Neuromuscular Block, Residual
Conditions
Brief summary
The purpose of this study is to assess the effect of quantitative block monitoring versus less expensive qualitative monitoring treatment effects on the lowest SpO2/FiO2 ratio in the PACU. The results will be incorporated into an enhanced recovery pathway for surgical patients.
Interventions
DEVICEQuantitative monitoring
The TetraGraph TOF monitor will be used to quantitatively assess the TOF-ratio. Quantitative monitoring includes objective measurement of the TOF-ratio, as defined by the ratio between the first and the fourth muscular responses and is quantified by acceleromyography. A TOF twitch response ratio equal or greater to 95% (TOF0.95) will be targeted prior to extubation. If TOF0.95 is not reached within 10 min of administering the initial dose of the respective reversal agent, redosing is recommended.
OTHERQualitative monitoring
Clinicians will assess the TOF-ratio. Qualitative monitoring includes subjective assessment of the count and the amplitude of the muscular responses related to neuromuscular block depth. A TOF twitch response count of 4 similarly strong twitches will be targeted prior to extubation. If 4 similarly strong TOF twitch responses are not reached within 10 min of administering the initial dose of the respective reversal agent, redosing is recommended.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Designated operating rooms of the hospital will be cluster randomized in this study. For each week of the 24-week trial, the designated operating rooms will be randomized to either quantitative or qualitative TOF monitoring.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient age ≥ 18 years old; * General anesthesia with endotracheal intubation; * Neuromuscular block with rocuronium.
Exclusion criteria
* Intubation before induction of anesthesia; * Critically ill patients admitted from the ICU; * Emergency cases; * Non-intubated patients; * Patients who will not be paralyzed through the surgery (spine). * Patients with an implanted electronic device (e.g. cardiac pacemaker) * Patients with allergies to adhesive * Patients with pre-existing neuromuscular disease (e.g. Myasthenia Gravis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lowest SpO2/FiO2 ratio in the PACU (constant for at least 10 minutes) | During the time in PACU (about 30 minutes to 6 hours) |
Secondary
| Measure | Time frame |
|---|---|
| Collapsed composite (any vs none) of postoperative pulmonary complications | During length of hospital stay (about 1 day to a week) |
Countries
United States
Contacts
Primary ContactMehmet Turan, MD
Backup ContactMohammad Khudirat
Outcome results
None listed