Observation of Neuromuscular Block
Conditions
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.
Interventions
Participants will have the extent of NMB monitored by a TOF-Watch SX®.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
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 | Up to 1 minute prior to tracheal extubation | 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 pollicis 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) | Up to 2 minutes prior to 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 pollicis 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 | Up to 1 minute prior to tracheal extubation | 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 pollicis 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 | Up to 2 minutes prior to 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 pollicis 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. |
Participant flow
Recruitment details
Participants were recruited at 8 sites in Canada between June 2011 and May 2012.
Participants by arm
| Arm | Count |
|---|---|
| TOF-Watch SX® All enrolled participants who had 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®. | 302 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device Malfunction | 10 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | TOF-Watch SX® |
|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 13.46 |
| Sex: Female, Male Female | 222 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 302 |
| serious Total, serious adverse events | 24 / 302 |
Outcome results
Primary
Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation
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 pollicis 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.
Time frame: Up to 1 minute prior to tracheal extubation
Population: Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TOF-Watch SX® | Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation | 56 percentage of participants |
Secondary
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
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 pollicis 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.
Time frame: Up to 1 minute prior to tracheal extubation
Population: The Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TOF-Watch SX® | 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 | TOF Ratio <0.6 | 19.1 percentage of participants |
| TOF-Watch SX® | 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 | TOF Ratio ≥0.6 to <0.7 | 11.6 percentage of participants |
| TOF-Watch SX® | 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 | TOF Ratio ≥0.7 to <0.8 | 8.7 percentage of participants |
| TOF-Watch SX® | 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 | TOF Ratio ≥0.8 to <0.9 | 16.6 percentage of participants |
| TOF-Watch SX® | 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 | TOF Ratio ≥0.9 | 44.0 percentage of participants |
Secondary
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
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 pollicis 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.
Time frame: Up to 2 minutes prior to PACU arrival
Population: The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TOF-Watch SX® | 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 | TOF Ratio <0.6 | 7.7 percentage of participants |
| TOF-Watch SX® | 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 | TOF Ratio ≥0.6 to <0.7 | 7.2 percentage of participants |
| TOF-Watch SX® | 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 | TOF Ratio ≥0.7 to <0.8 | 13.5 percentage of participants |
| TOF-Watch SX® | 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 | TOF Ratio ≥0.8 to <0.9 | 15.5 percentage of participants |
| TOF-Watch SX® | 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 | TOF Ratio ≥0.9 | 56.0 percentage of participants |
Secondary
Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)
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 pollicis 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.
Time frame: Up to 2 minutes prior to PACU arrival
Population: The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TOF-Watch SX® | Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU) | 44 percentage of participants |