Phase 4
N=302
Residual Curarization and Its Incidence at Tracheal Extubation (P08194)
Observation of Neuromuscular Block
Bottom Line
View on ClinicalTrials.gov: NCT01318382 ↗Enrolled (actual)
302
Serious AEs
8.0%
Results posted
May 2013
Primary outcome: Primary: Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation — 56 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- TOF-Watch SX® Monitoring of NMB (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation |
56 | — |
| SECONDARY Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU) |
44 | — |
| SECONDARY Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation |
19.1; 11.6; 8.7; 16.6; 44.0 | — |
| SECONDARY Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU |
7.7; 7.2; 13.5; 15.5; 56.0 | — |
Summary
This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for participants whose non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase inhibitor administered as per standard routine care.
Eligibility Criteria
Inclusion Criteria
- Participant must be American Society of Anesthesia (ASA) class 1-3.
- Participant must be scheduled for elective open or laparoscopic abdominal surgery that is anticipated to last less than 4 hours.
- Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular blockers for endotracheal intubation or maintenance of neuromuscular blockade.
- Extubation must occur in the operating room (OR).
Exclusion Criteria
- Surgery re-admission on the same hospital admission.
- Pre-established need for or expected to require post-operative mechanical ventilation.
- Conditions, surgical procedures or position that may interfere with the TOF-Watch SX® operation, calibration or accuracy.
- Administration of sugammadex (Bridion®) for reversal of neuromuscular blockade.
- Participation in any other clinical trial.
- Member or a family member of the personnel of the investigational or Sponsor staff directly involved with this trial.
- Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method).
Data sourced from ClinicalTrials.gov (NCT01318382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.