Residual Curarization and Its Incidence at Tracheal Extubation (P08194) (RECITE)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Observation of Neuromuscular Block

Treatments: Device: TOF-Watch SX® Monitoring of NMB

Study type: Interventional

Funder types: Industry

Identifiers

NCT01318382

MK-8616-063 (Other Identifier)

P08194

Details and patient eligibility

About

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.

Full description

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

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

302 participants in 1 patient group

TOF-Watch SX®

Experimental group

Description:

Participants who have undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.

Treatment:

Device: TOF-Watch SX® Monitoring of NMB