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| ID | Type | Description | Link |
|---|---|---|---|
| 19.4.334 | Other Identifier | Merck |
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The primary purpose of this study is to compare the incidence of
residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch (T4/T1) ratio of
< 0.90.
Undetected residual neuromuscular blockade is common in the post-anesthesia care
unit (PACU). In fact, 16%-42% of patients receiving intermediate-acting muscle
relaxants in the operating room have T4/T1 ratios <0.7-0.8 in the PACU. Respiratory and pharyngeal muscle function can be adversely affected during minimal neuromuscular blockade. Studies in awake volunteers and surgical patients have demonstrated that T4/T1 ratios of 0.7 - 0.9 are associated with impaired airway protective reflexes, upper airway obstruction, a decreased hypoxic ventilatory response, and post-operative hypoxemia. The incidence and severity of residual neuromuscular blockade at the time of tracheal extubation will be evaluated to determine how these influence the length of stay in the operating room and PACU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | 4 mg/kg sugammadex |
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| Neostigmine | Active Comparator | 50 µg/kg neostigmine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Participants received 4 mg/kg sugammadex at 1-2 Post Tetanic Counts (PTCs) or better after the last dose of rocuronium bromide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual Neuromuscular Blockade Evidenced by T4/T1 Ratio at the Time of Tracheal Extubation | Neuromuscular function was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds, and assessing twitch response at the adductor pollicis muscle with a TOF-Watch® SX. The magnitudes (heights) of the first and fourth twitches (T1 and T4) were used to calculate the T4/T1 ratio, where a higher T4/T1 ratio indicates a greater recovery from neuromuscular blockade, with a value of 1.0 indicating complete recovery. After anesthesia, when neuromuscular function was expected to be fully recovered, tracheal extubation was performed, at which time the T4/T1 ratio was measured, with any missing recovery times imputed. | Up to the first 24 hours after tracheal extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post-operative Complications | Post-operative complications include any of the following: procedural pain, nausea, vomiting, incision-site pain, constipation, headache, pyrexia, dizziness and pruritus. | Up to 7 days after surgery |
| Number of Participants With Evidence of Possible Interaction of Sugammadex With Endogenous Compounds or Exogenous Compounds Other Than Rocuronium Bromide |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Sabo D, Jones RK, Berry J, Sloan T, Chen J-Y, Morte JB, Groudine S. Residual neuromuscular blockade at extubation: a randomized comparison of sugammadex and neostigmine reversal of rocuronium-induced blockade in patients undergoing abdominal surgery. J Anesthe Clin Res. 2011;2:140. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | 4 mg/kg sugammadex |
| FG001 | Neostigmine | 50 µg/kg neostigmine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Neostigmine | Drug | Participants received 50 µg/kg neostigmine combined with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care. |
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| Rocuronium | Drug | Participants received a single intubation bolus dose of 0.6 mg/kg rocuronium bromide, followed if necessary to maintain neuromuscular blockade by one or more single bolus dose(s) of 0.15 mg/kg rocuronium bromide. |
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Evidence of adverse events due to a possible interaction of sugammadex with exogenous compounds or endogenous compounds other than rocuronium was recorded. |
| Up to 7 days after surgery |
| Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.9, with imputed data included. | Up to 1 hour after treatment |
| Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.8, with imputed data included. | Up to 1 hour after treatment |
| Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.7, with imputed data included. | Up to 1 hour after treatment |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | 4 mg/kg sugammadex |
| BG001 | Neostigmine | 50 µg/kg neostigmine |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Residual Neuromuscular Blockade Evidenced by T4/T1 Ratio at the Time of Tracheal Extubation | Neuromuscular function was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds, and assessing twitch response at the adductor pollicis muscle with a TOF-Watch® SX. The magnitudes (heights) of the first and fourth twitches (T1 and T4) were used to calculate the T4/T1 ratio, where a higher T4/T1 ratio indicates a greater recovery from neuromuscular blockade, with a value of 1.0 indicating complete recovery. After anesthesia, when neuromuscular function was expected to be fully recovered, tracheal extubation was performed, at which time the T4/T1 ratio was measured, with any missing recovery times imputed. | Intent to treat (ITT) group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis. | Posted | Mean | Standard Deviation | T4/T1 Ratio | Up to the first 24 hours after tracheal extubation |
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| Secondary | Number of Participants With Post-operative Complications | Post-operative complications include any of the following: procedural pain, nausea, vomiting, incision-site pain, constipation, headache, pyrexia, dizziness and pruritus. | All subjects treated (AST) group consisting of randomized participants who were treated with sugammadex or neostigmine | Posted | Number | participants | Up to 7 days after surgery |
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| Secondary | Number of Participants With Evidence of Possible Interaction of Sugammadex With Endogenous Compounds or Exogenous Compounds Other Than Rocuronium Bromide | Evidence of adverse events due to a possible interaction of sugammadex with exogenous compounds or endogenous compounds other than rocuronium was recorded. | All subjects treated (AST) group consisting of randomized participants who were treated with sugammadex or neostigmine | Posted | Number | participants | Up to 7 days after surgery |
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| Secondary | Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.9, with imputed data included. | ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis. | Posted | Mean | Standard Deviation | Minutes | Up to 1 hour after treatment |
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| Secondary | Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.8, with imputed data included. | ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis. | Posted | Mean | Standard Deviation | Minutes | Up to 1 hour after treatment |
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| Secondary | Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.7, with imputed data included. | ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis. | Posted | Mean | Standard Deviation | Minutes | Up to 1 hour after treatment |
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Up to 7 days after administration of IMP
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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 | Sugammadex | 4 mg/kg sugammadex | 4 | 51 | 51 | 51 | ||
| EG001 | Neostigmine | 50 µg/kg neostigmine | 6 | 49 | 49 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 |
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| Constipation | Gastrointestinal disorders | MedDRA 11.1 |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 |
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| Pelvic abscess | Infections and infestations | MedDRA 11.1 |
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| Wound infection staphylococcal | Infections and infestations | MedDRA 11.1 |
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| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA 11.1 |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.1 |
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| Constipation | Gastrointestinal disorders | MedDRA 11.1 |
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| Flatulence | Gastrointestinal disorders | MedDRA 11.1 |
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| Ileus | Gastrointestinal disorders | MedDRA 11.1 |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.1 |
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| Pyrexia | General disorders | MedDRA 11.1 |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.1 |
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| Dizziness | Nervous system disorders | MedDRA 11.1 |
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| Headache | Nervous system disorders | MedDRA 11.1 |
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| Insomnia | Psychiatric disorders | MedDRA 11.1 |
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| Bladder spasm | Renal and urinary disorders | MedDRA 11.1 |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
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In case a proposed publication contains reference to an invention owned by the sponsor or to which the sponsor otherwise has rights, the sponsor may request a reasonable suspension of the publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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