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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8616-063 | Other Identifier | Merck Protocol ID |
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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.
This is an observational cohort study with a device intervention to determine in which cohort the subject is falling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOF-Watch SX® | Experimental | 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®. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOF-Watch SX® Monitoring of NMB | Device | Participants will have the extent of NMB monitored by a TOF-Watch SX®. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 minute prior to tracheal extubation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25902322 | Result | Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757. |
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Participants were recruited at 8 sites in Canada between June 2011 and May 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 neuromuscular blockade (NMB) monitored by a TOF-Watch SX®. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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®. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1 minute prior to tracheal extubation |
|
Through Day 1 (up to one day after surgery)
The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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®. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus Paralytic | Gastrointestinal disorders | MedDRA 15.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| Up to 2 minutes prior to PACU arrival |
| 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. | Up to 1 minute prior to tracheal extubation |
| 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. | Up to 2 minutes prior to PACU arrival |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation. |
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 minutes prior to PACU arrival |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1 minute prior to tracheal extubation |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 minutes prior to PACU arrival |
|
|
|
| 24 |
| 302 |
| 0 |
| 302 |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 |
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| Chest Pain | General disorders | MedDRA 15.0 |
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| Oedema Peripheral | General disorders | MedDRA 15.0 |
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| Pain | General disorders | MedDRA 15.0 |
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| Clostridial Infection | Infections and infestations | MedDRA 15.0 |
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| Wound Infection | Infections and infestations | MedDRA 15.0 |
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| Anastomotic Leak | Injury, poisoning and procedural complications | MedDRA 15.0 |
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| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA 15.0 |
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| Procedural Complication | Injury, poisoning and procedural complications | MedDRA 15.0 |
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| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 15.0 |
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| Electrocardiogram T Wave Inversion | Investigations | MedDRA 15.0 |
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| Oxygen Saturation Decreased | Investigations | MedDRA 15.0 |
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| Urinary Retention | Renal and urinary disorders | MedDRA 15.0 |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
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| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
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| Explorative Laparotomy | Surgical and medical procedures | MedDRA 15.0 |
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| Hypovolaemic Shock | Vascular disorders | MedDRA 15.0 |
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The investigator agrees to provide copies of abstracts or manuscripts for publication that report any results of the trial to the Sponsor 45 days prior to submission for publication or presentation.
| Title | Measurements |
|---|---|
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| TOF Ratio ≥0.8 to <0.9 |
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| TOF Ratio ≥0.9 |
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| Title | Measurements |
|---|---|
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| TOF Ratio ≥0.8 to <0.9 |
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| TOF Ratio ≥0.9 |
|