Residual Curarization and Its Incidence at Tracheal Extubation in China (RECITE-China)

Xinmin Wu

Status: Completed

Conditions: Residual Curarization

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01871064

LCE50498

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 a prospective, multi-site, anesthesiologist and PACU nurse TOF-Watch SX® blinded observational study of surgical patients undergoing elective laparoscopic or open abdominal procedures requiring general anesthesia and non-depolarizing neuromuscular blockade. There are two temporal aspects to the data collection: a prospective data collection in the OR and PACU; and a retrospective chart review one week after hospital discharge.

Enrollment: 1,571 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age≥18;
• American Society of Anesthesiologists(ASA) class 1-3;
• 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;
• Planned for extubation to occur in the OR;
• Signed informed consent.

Exclusion criteria

• Redo surgery on the same hospital admission;
• Pre-established need or expected to require post-operative mechanical ventilation;
• Conditions, surgical procedures, or participant positioning that may interfere with TOF-Watch SX® operation, calibration, or accuracy;
• Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method);
• Pregnancy;
• 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.