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| ID | Type | Description | Link |
|---|---|---|---|
| 19.4.335 |
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The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex in Caucasian Subjects | Experimental | At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe. |
|
| Sugammadex in Chinese Subjects | Experimental | At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could have been administered if necessary. At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Administration of Sugammadex to Recovery of the 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. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary. | Start of administration of sugammadex to recovery from neuromuscular blockade |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7 | 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. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. | Start of administration of sugammadex to recovery from neuromuscular blockade |
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Inclusion Criteria:
-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using
rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).
For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.
Exclusion Criteria:
-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the
(family of) study/sponsor staff.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Yu B, Wang X, Helbo Hansen HS, Huang W-Q, Askeland B, Li S, Ding Z, Abels E, Rietbergen H, Woo T, Pendeville P. Sugammadex 4.0 mg/kg reversal of deep rocuronium-induced neuromuscular blockade: a multicenter study in Chinese and Caucasian patients. J Anesthe Clin Res. 2014;5:408. doi: 10.4172/2155-6148.1000408 |
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Two subjects were screened but not enrolled (one Chinese subject and one Caucasian subject).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex in Chinese Subjects | At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China. |
| FG001 | Sugammadex in Caucasian Subjects | At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex in Chinese Subjects | At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China. |
| BG001 | Sugammadex in Caucasian Subjects |
| 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 to Recovery of the 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. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary. | The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS. | Posted | Geometric Mean | 95% Confidence Interval | minutes | Start of administration of sugammadex to recovery from neuromuscular blockade |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex in Chinese Subjects | At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (13.1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | MedDRA (13.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
|
| Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8 | 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. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. | Start of administration of sugammadex to recovery from neuromuscular blockade |
| Administrative |
|
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Sugammadex in Chinese Subjects | At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China. |
| OG001 | Sugammadex in Caucasian Subjects | At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe. |
|
|
|
| Secondary | Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7 | 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. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. | The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS. | Posted | Geometric Mean | 95% Confidence Interval | minutes | Start of administration of sugammadex to recovery from neuromuscular blockade |
|
|
|
| Secondary | Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8 | 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. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. | The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS. | Posted | Geometric Mean | 95% Confidence Interval | minutes | Start of administration of sugammadex to recovery from neuromuscular blockade |
|
|
|
| 0 |
| 115 |
| 46 |
| 115 |
| EG001 | Sugammadex in Caucasian Subjects | At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe. | 1 | 36 | 20 | 36 |
| abdominal pain lower | Gastrointestinal disorders | MedDRA (13.1) |
|
| nausea | Gastrointestinal disorders | MedDRA (13.1) |
|
| vomiting | Gastrointestinal disorders | MedDRA (13.1) |
|
| instillation site erythema | General disorders | MedDRA (13.1) |
|
| incision site pain | Injury, poisoning and procedural complications | MedDRA (13.1) |
|
| procedural hypotension | Injury, poisoning and procedural complications | MedDRA (13.1) |
|
| wound complication | Injury, poisoning and procedural complications | MedDRA (13.1) |
|
| dizziness | Nervous system disorders | MedDRA (13.1) |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) |
|
| rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) |
|
Investigator may not publish/publicly present interim results without prior consent of Sponsor. Any materials that report results of the study must be sent to Sponsor 45 days prior to submission for publication/presentation. Sponsor has right to review and comment. In case of any disagreements concerning appropriateness of the materials, investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues or disagreement, prior to submission for publication/presentation.
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |