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| ID | Type | Description | Link |
|---|---|---|---|
| 19.4.303 | Other Identifier | Organon Protocol Number | |
| P05946 | Other Identifier | Schering-Plough Protocol Number | |
| MK-8616-026 | Other Identifier | Merck Protocol Number |
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The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocuronium + Sugammadex | Experimental | Participants were to receive a single bolus dose of 1.2 mg/kg rocuronium. Three minutes after the start of the rocuronium administration, they were to receive a single bolus dose of 16.0 mg/kg sugammadex. |
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| Succinylcholine | Active Comparator | Participants were to receive a single bolus dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration | 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 refers to the amplitude (height) of the first twitch after TOF nerve stimulation. | Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Recovery of T1 to 90% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration | 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 refers to the amplitude (height) of the first twitch after TOF nerve stimulation. | Up to 20 minutes after administration of rocuronium + sugammadex or succinylcholine |
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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 |
|---|---|---|---|
| 19387176 | Derived | Lee C, Jahr JS, Candiotti KA, Warriner B, Zornow MH, Naguib M. Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Anesthesiology. 2009 May;110(5):1020-5. doi: 10.1097/ALN.0b013e31819dabb0. |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Rocuronium + Sugammadex | Participants received a single bolus intravenous (IV) dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg three minutes after the start of rocuronium administration, to reverse the neuromuscular block. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Succinylcholine | Drug | Single bolus IV dose of 1.0 mg/kg succinylcholine |
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| Rocuronium | Drug | Single bolus IV dose of 1.2 mg/kg rocuronium |
|
|
| Level of Consciousness: Number of Participants Awake and Oriented | The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness. The clinical level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated. | Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine |
| Level of Consciousness: Number of Participants Arousable With Minimal Stimulation | The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated. | Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine |
| Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation | The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated. | Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine |
| Number of Participants Able to Perform 5-Second Head Lift | The number of participants who were able to lift their head for 5 seconds was assessed as a measure of recovery following neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved. | Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine |
| Number of Participants Experiencing General Muscle Weakness | The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups. | Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine |
| Succinylcholine |
Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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All participants who received study treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Rocuronium + Sugammadex | Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block. |
| BG001 | Succinylcholine | Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block. |
| 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 | Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration | 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 refers to the amplitude (height) of the first twitch after TOF nerve stimulation. | All participants who received study treatment and had at least one post-baseline efficacy assessment | Posted | Mean | Standard Deviation | Minutes | Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine |
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| Secondary | Time to Recovery of T1 to 90% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration | 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 refers to the amplitude (height) of the first twitch after TOF nerve stimulation. | All participants who received study treatment and had at least one post-baseline efficacy assessment | Posted | Mean | Standard Deviation | Minutes | Up to 20 minutes after administration of rocuronium + sugammadex or succinylcholine |
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| |||||||||||||||||||||||||||||
| Secondary | Level of Consciousness: Number of Participants Awake and Oriented | The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness. The clinical level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated. | All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations | Posted | Count of Participants | Participants | Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine |
| |||||||||||||||||||||||||||||||
| Secondary | Level of Consciousness: Number of Participants Arousable With Minimal Stimulation | The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated. | All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations | Posted | Count of Participants | Participants | Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine |
| |||||||||||||||||||||||||||||||
| Secondary | Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation | The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated. | All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations | Posted | Count of Participants | Participants | Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine |
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| Secondary | Number of Participants Able to Perform 5-Second Head Lift | The number of participants who were able to lift their head for 5 seconds was assessed as a measure of recovery following neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved. | All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations | Posted | Count of Participants | Participants | Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine |
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| Secondary | Number of Participants Experiencing General Muscle Weakness | The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups. | All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations | Posted | Count of Participants | Participants | Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine |
|
Up to 7 days after administration of rocuronium + sugammadex or succinylcholine
All participants who received study treatment
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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 | Participants received a single bolus IV dose of 1.2 mg/kg rocuronium to induce neuromuscular block. This was followed by a single bolus IV dose of sugammadex 16.0 mg/kg 3 minutes after the start of rocuronium administration, to reverse the neuromuscular block. | 0 | 56 | 0 | 56 | 51 | 56 |
| EG001 | Succinylcholine | Participants received a single bolus IV dose of 1.0 mg/kg succinylcholine to induce neuromuscular block. They were allowed to recovery spontaneously from the neuromuscular block. | 0 | 54 | 1 | 54 | 50 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic haematoma | Reproductive system and breast disorders | MedDRA 9.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 9.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
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| Incision site complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Procedural complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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The Sponsor recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning this clinical trial 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.
| 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 |
| D013390 | Succinylcholine |
| 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 |
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009861 | Onium Compounds |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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