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Residual Curarization and Its Incidence at Tracheal Extubation in China

18 Years
Open (Enrolling)
Residual Curarization

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Trial Information

Residual Curarization and Its Incidence at Tracheal Extubation in China

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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation

Outcome Description:

Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollices muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.

Outcome Time Frame:

Immediately prior to tracheal extubation in the OR

Safety Issue:


Principal Investigator

Xinmin Wu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University First Hospital


China: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

December 2013

Related Keywords:

  • Residual Curarization
  • Laparotomy
  • laparoscopic surgery
  • general anesthesia
  • Neuromuscular Block