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| ID | Type | Description | Link |
|---|---|---|---|
| 19.4.305 | Other Identifier | Organon Study Number | |
| P05950 | Other Identifier | Schering-Plough Study Number | |
| MK-8616-029 | Other Identifier | Merck Protocol Number |
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The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants 18 to 64 years old | Experimental | Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
|
| Participants 65 to 74 years old | Experimental | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
|
| Participants 75 years and older | Experimental | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9 | Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. | up to 10 minutes from start of sugammadex |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7 | Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21239968 | Result | McDonagh DL, Benedict PE, Kovac AL, Drover DR, Brister NW, Morte JB, Monk TG. Efficacy, safety, and pharmacokinetics of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in elderly patients. Anesthesiology. 2011 Feb;114(2):318-29. doi: 10.1097/ALN.0b013e3182065c36. |
| 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 | Participants 18 to 64 Years Old | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rocurium | Drug | intravenous (IV) single bolus dose of 0.6 mg.kg-1 |
|
| up to 10 minutes from start of sugammadex |
| Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8 | Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. | up to 10 minutes from start of sugammadex |
| Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation | Participants level of consciousness was assessed post-extubation and prior to transfer to recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized. | Prior to Transfer to the Recovery Room After Extubation (up to 24 hours) |
| Participants Level of Consciousness Prior to Discharge From Recovery Room | Participants level of consciousness was assessed prior to discharge from the recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized. | Prior to Discharge from Recovery Room (up to 24 hours) |
| Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation | The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade post-extubation and prior to transfer to recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as "yes" or "no" to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment. | Prior to Transfer to the Recovery Room After Extubation (up to 24 hours) |
| Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room | The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade prior to discharge from the recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as "yes" or "no" to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment. | Prior to Discharge from Recovery Room (up to 24 hours) |
| Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation | Participants were asked to lift their head off the table while in a supine position post-extubation and prior to transfer to recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment. | Prior to Transfer to the Recovery Room After Extubation (up to 24 hours) |
| Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room | Participants were asked to lift their head off the table while in a supine position just prior to discharge from the recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment. | Prior to Discharge from Recovery Room (up to 24 hours) |
| FG001 | Participants 65 to 74 Years Old | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
| FG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Baseline characteristics are provided for all participants that received study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants 18 to 64 Years Old | Participants to receive an intravenous IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
| BG001 | Participants 65 to 74 Years Old | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
| BG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9 | Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. | All participants that received study drug and had at least 1 post-baseline efficacy measurement. Missing data were imputed. | Posted | Mean | Standard Deviation | Minutes | up to 10 minutes from start of sugammadex |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7 | Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. | All participants that received study drug and had at least 1 post-baseline efficacy measurement. Missing data were imputed. | Posted | Mean | Standard Deviation | Minutes | up to 10 minutes from start of sugammadex |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8 | Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. | All participants that received study drug and had at least 1 post-baseline efficacy measurement. Missing data were imputed. | Posted | Mean | Standard Deviation | Minutes | up to 10 minutes from start of sugammadex |
| |||||||||||||||||||||||||||||||||
| Secondary | Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation | Participants level of consciousness was assessed post-extubation and prior to transfer to recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized. | All participants that received study drug, had at least 1 post-baseline efficacy measurement and had data available for endpoint. | Posted | Number | Participants | Prior to Transfer to the Recovery Room After Extubation (up to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Participants Level of Consciousness Prior to Discharge From Recovery Room | Participants level of consciousness was assessed prior to discharge from the recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized. | All participants that received study drug and had at least 1 post-baseline efficacy measurement and had data available for endpoint | Posted | Number | Participants | Prior to Discharge from Recovery Room (up to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation | The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade post-extubation and prior to transfer to recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as "yes" or "no" to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment. | All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative. | Posted | Number | Participants | Prior to Transfer to the Recovery Room After Extubation (up to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room | The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade prior to discharge from the recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as "yes" or "no" to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment. | All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative. | Posted | Number | Participants | Prior to Discharge from Recovery Room (up to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation | Participants were asked to lift their head off the table while in a supine position post-extubation and prior to transfer to recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment. | All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative. | Posted | Number | Participants | Prior to Transfer to the Recovery Room After Extubation (up to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room | Participants were asked to lift their head off the table while in a supine position just prior to discharge from the recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment. | All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative. | Posted | Number | Participants | Prior to Discharge from Recovery Room (up to 24 hours) |
|
up to 7 days after administration of the study drug
Population included all participants that received study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants 18 to 64 Years Old | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. | 0 | 48 | 4 | 48 | 48 | 48 |
| EG001 | Participants 65 to 74 Years Old | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. | 0 | 62 | 8 | 62 | 62 | 62 |
| EG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. | 0 | 40 | 3 | 40 | 40 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Abdominal haematoma | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Metastatic carcinoma of the bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Post procedural nausea | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
All publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in the 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.
| 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 |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
| OG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
|
|
| OG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
|
|
| OG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
|
|
| OG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
|
|
| OG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
|
|
| OG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
|
|
| OG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
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| OG002 | Participants 75 Years and Older | Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. |
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