Residual Curarization
Conditions
Keywords
Laparotomy, laparoscopic surgery, general anesthesia, Neuromuscular Block
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 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.
Interventions
Participants will have the extent of NMB monitored by a TOF-Watch SX®.
Sponsors
Merck Sharp & Dohme LLC
Xinmin Wu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation | Immediately prior to tracheal extubation in the OR | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU) | Immediately upon PACU arrival | Neuromuscular functioning was monitored at time of PACU arrival 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. |
| 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 | Immediately prior to tracheal extubation in the OR | 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 |
| 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 | Immediately upon PACU Arrival | Neuromuscular functioning was monitored at time of PACU arrival 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. |
Countries
China
Outcome results
None listed