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| ID | Type | Description | Link |
|---|---|---|---|
| 19.4.308 | Other Identifier | Organon Protocol Number | |
| P05932 | Other Identifier | Schering-Plough Protocol Number | |
| MK-8616-017 | Other Identifier | Merck Protocol Number |
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The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | Experimental | After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 2.0 mg/kg. |
|
| Rocuronium + Sugammadex 4.0 mg/kg | Experimental | After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 4.0 mg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Sugammadex solution for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease | The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.9 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX. | Up to 90 minutes |
| Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE) | The percentage of participants experiencing ≥1 AE(s) was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Up to 7 days |
| Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE) | The percentage of participants discontinuing from study treatment due to an AE was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease | The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.7 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX. |
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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 |
|---|---|---|---|
| 22608583 | Derived | Amao R, Zornow MH, Cowan RM, Cheng DC, Morte JB, Allard MW. Use of sugammadex in patients with a history of pulmonary disease. J Clin Anesth. 2012 Jun;24(4):289-97. doi: 10.1016/j.jclinane.2011.09.006. |
| 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 were enrolled at 9 study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rocuronium + Sugammadex 2.0 mg/kg | After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg. |
| FG001 | Rocuronium + Sugammadex 4.0 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rocuronium | Drug | Rocuronium bromide solution for injection. |
|
|
| Up to 90 minutes |
| Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease | The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.8 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX. | Up to 90 minutes |
| Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | The level of consciousness prior to transfer to the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation. | Up to 6 hours (prior to transfer to the recovery room after extubation) |
| Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room | The level of consciousness prior to discharge from the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation. | Up to 6 hours (prior to discharge from the recovery room) |
| Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task. | Up to 6 hours (prior to transfer to the recovery room after extubation) |
| Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room | The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task. | Up to 6 hours (prior to discharge from the recovery room) |
| General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician. | Up to 6 hours (prior to transfer to the recovery room after extubation) |
| General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room | Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician. | Up to 6 hours (prior to discharge from the recovery room) |
After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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All treated participants are included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rocuronium + Sugammadex 2.0 mg/kg | After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg. |
| BG001 | Rocuronium + Sugammadex 4.0 mg/kg | After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg. |
| BG002 | 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 | Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease | The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.9 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX. | All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 11 participants (2.0 mg/kg n=6 and 4.0 mg/kg n=5), data were missing due to watch malfunction (n=2), the data that was obtained was considered unreliable (n=6), or the watch was removed prior to recovery to 0.9 (n=3). | Posted | Mean | Standard Deviation | Minutes | Up to 90 minutes |
|
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| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE) | The percentage of participants experiencing ≥1 AE(s) was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | All randomized participants who received sugammadex are included. | Posted | Number | Percentage of Participants | Up to 7 days |
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE) | The percentage of participants discontinuing from study treatment due to an AE was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | All randomized participants who received sugammadex are included. | Posted | Number | Percentage of Participants | Up to 7 days |
| |||||||||||||||||||||||||||||||
| Secondary | Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease | The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.7 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX. | All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 6 participants (2.0 mg/kg n=3 and 4.0 mg/kg n=3), data were unavailable due to TOF-Watch® malfunction (n=2), or the data that was obtained was considered unreliable (n=4). | Posted | Mean | Standard Deviation | Minutes | Up to 90 minutes |
| ||||||||||||||||||||||||||||||
| Secondary | Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease | The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.8 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX. | All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 7 participants (2.0 mg/kg n=4 and 4.0 mg/kg n=3), data were unavailable due to TOF-Watch® malfunction (n=2), or the data that was obtained was considered unreliable (n=5). | Posted | Mean | Standard Deviation | Minutes | Up to 90 minutes |
| ||||||||||||||||||||||||||||||
| Secondary | Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | The level of consciousness prior to transfer to the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation. | All randomized participants who received sugammadex and had ≥1 post-baseline assessment for the outcome measure. One participant in the 4.0 mg/kg group had missing data. | Posted | Count of Participants | Participants | Up to 6 hours (prior to transfer to the recovery room after extubation) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room | The level of consciousness prior to discharge from the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation. | All randomized participants who received sugammadex and had ≥1 post-baseline assessment for the outcome measure. | Posted | Count of Participants | Participants | Up to 6 hours (prior to discharge from the recovery room) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task. | All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. | Posted | Count of Participants | Participants | Up to 6 hours (prior to transfer to the recovery room after extubation) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room | The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task. | All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. | Posted | Count of Participants | Participants | Up to 6 hours (prior to discharge from the recovery room) |
|
| ||||||||||||||||||||||||||||||
| Secondary | General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician. | All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. | Posted | Count of Participants | Participants | Up to 6 hours (prior to transfer to the recovery room after extubation) |
|
| ||||||||||||||||||||||||||||||
| Secondary | General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room | Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician. | All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. | Posted | Count of Participants | Participants | Up to 6 hours (prior to discharge from the recovery room) |
|
|
Up to 7 days
All randomized participants who received sugammadex are included.
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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 2.0 mg | After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg. | 0 | 39 | 4 | 39 | 38 | 39 |
| EG001 | Rocuronium + Sugammadex 4.0 mg | After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg. | 0 | 38 | 3 | 38 | 34 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Poor peripheral circulation | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | 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 |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 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 |
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| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Post procedural nausea | 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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| Beta 2 microglobulin increased | Investigations | MedDRA 9.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
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| Urine output decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| Back pain | 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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| Insomnia | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal 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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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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Any such 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.
| 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 |
| 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 |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Male |
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| Participants |
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| Units |
|---|
| Counts |
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| Participants |
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After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
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After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg.
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| Participants |
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