Clinical trial NCT01318382: Residual Curarization and Its Incidence at Tracheal Extubation (P08194)
Official title: Residual Curarization and Its Incidence at Tracheal Extubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Observation of Neuromuscular Block
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: This is an observational cohort study with a device intervention to determine in which cohort the subject is falling.

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).

Primary outcomes:
measure: Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation
timeFrame: Up to 1 minute prior to tracheal extubation
Secondary outcomes:
measure: Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)
timeFrame: Up to 2 minutes prior to PACU arrival
measure: 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
timeFrame: Up to 1 minute prior to tracheal extubation
measure: 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
timeFrame: Up to 2 minutes prior to PACU arrival
Other outcomes:
Locations:
Study officials:
References:
citation: Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.