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| ID | Type | Description | Link |
|---|---|---|---|
| 19.4.301 | Other Identifier | Organon Protocol Number | |
| MK-8616-033 | Other Identifier | Merck Protocol Number |
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The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocuronium + Sugammadex | Experimental | After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered |
|
| Rocuronium + Neostigmine | Active Comparator | After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered |
|
| Vecuronium + Sugammadex | Experimental | After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered |
|
| Vecuronium + Neostigmine | Active Comparator | After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. | Neuromuscular functioning 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. T1 and T4 refer to the amplitudes (heights) 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 neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB. | Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) 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. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19713265 | Result | Khuenl-Brady KS, Wattwil M, Vanacker BF, Lora-Tamayo JI, Rietbergen H, Alvarez-Gomez JA. Sugammadex provides faster reversal of vecuronium-induced neuromuscular blockade compared with neostigmine: a multicenter, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):64-73. doi: 10.1213/ane.0b013e3181ac53c3. Epub 2009 Aug 27. | |
| 20683334 |
| Label | URL |
|---|---|
| Click here to access a synopsis of the study results. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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Participants who had a surgical procedure using a general anesthesia of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rocuronium + Sugammadex | After the last dose of rocuronium, at reappearance of second twitch (T2), a dose of 2.0 mg/kg sugammadex was administered |
| FG001 | Rocuronium + Neostigmine | After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered |
| FG002 | Vecuronium + Sugammadex | After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered |
| FG003 | Vecuronium + Neostigmine | After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Participants As Treated
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| ID | Title | Description |
|---|---|---|
| BG000 | Rocuronium + Sugammadex | After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered |
| BG001 | Rocuronium + Neostigmine | After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. | Neuromuscular functioning 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. T1 and T4 refer to the amplitudes (heights) 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 neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB. | All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times. | Posted | Mean | Standard Deviation | Minutes | Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 |
|
Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
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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 | Rocuronium + Sugammadex | After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subileus | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| Neostigmine | Drug | After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered |
|
|
| Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 |
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) 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. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB. | Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 |
| Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness | Day 1 |
| Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness | Day 1 |
| Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. Eur J Anaesthesiol. 2010 Oct;27(10):874-81. doi: 10.1097/EJA.0b013e32833d56b7. |
| Withdrawal by Subject |
|
| Not Treated |
|
| BG002 | Vecuronium + Sugammadex | After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered |
| BG003 | Vecuronium + Neostigmine | After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Rocuronium + Sugammadex | After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered |
| OG001 | Rocuronium + Neostigmine | After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered |
| OG002 | Vecuronium + Sugammadex | After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered |
| OG003 | Vecuronium + Neostigmine | After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered |
|
|
| Secondary | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) 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. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB. | All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times. | Posted | Mean | Standard Deviation | Minutes | Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 |
|
|
|
| Secondary | Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) 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. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB. | All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times. | Posted | Mean | Standard Deviation | Minutes | Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 |
|
|
|
| Secondary | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation | After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness | All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room | Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness | All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. One participant from the Rocuronium + Sugammadex treatment group, and one participant from the Vecuronium + Neostigmine treatment group were not analyzed. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 48 |
| 2 |
| 48 |
| 37 |
| 48 |
| EG001 | Rocuronium + Neostigmine | After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered | 0 | 48 | 3 | 48 | 40 | 48 |
| EG002 | Vecuronium + Sugammadex | After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered | 0 | 48 | 0 | 48 | 32 | 48 |
| EG003 | Vecuronium + Neostigmine | After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered | 0 | 45 | 0 | 45 | 35 | 45 |
| Postoperative infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Airway complication of anaesthesia | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Neuromuscular block prolonged | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Post procedural nausea | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Post procedural vomiting | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
Any scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
| 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 |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Consciousness: Arousable with minimal stimulation |
|
| Consciousness: Responsive only to tactile stimuli |
|
| Able to perform the 5 second head lift |
|
| Has general muscle weakness |
|
| Consciousness: Arousable with minimal stimulation |
|
| Consciousness: Responsive only to tactile stimuli |
|
| Able to perform the 5 second head lift |
|
| Has general muscle weakness |
|