E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate faster recovery in subjects undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a T4/T1 ratio of 0.9, after reversal of a target depth of neuromuscular blockade of 1-2 PTC by 4.0 mg.kg-1 sugammadex compared to placebo |
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E.2.2 | Secondary objectives of the trial |
− To evaluate the safety of 4.0 mg.kg-1 sugammadex in subjects undergoing elective surgery requiring profound neuromuscular blockade induced by rocuronium compared to placebo − To evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for subjects undergoing elective surgery requiring profound neuromuscular blockade induced by rocuronium reversed by 4.0 mg.kg-1 sugammadex compared to placebo
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects of ASA (American Society of Anesthesiologists) class 1, 2 or 3 2. Subjects of age ≥ 18 years 3. Subjects who are scheduled to undergo a surgery requiring profound neuromuscular blockade such as cardiovascular, gynaecologic, neurologic and thoracic surgical procedures under general anesthesia requiring neuromuscular relaxation with rocuronium for endotracheal intubation and if applicable maintenance of neuromuscular blockade in a position allowing neuromuscular monitoring 4. Subjects who have given written informed consent
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E.4 | Principal exclusion criteria |
1. Subjects known or expected to have a difficult intubation because of anatomical malformations 2. Subjects known or expected to be transferred to the Intensive Care Unit (ICU) after surgery 3. Subjects known or suspected to have neuromuscular disorders affecting Neuromuscular Blockade (NMB) 4. Subjects known or suspected to have a significant hepatic dysfunction that would prevent participation in this trial as determined by the investigator 5. Subjects known or suspected to have a significant renal dysfunction that would prevent participation in this trial as determined by the investigator 6. Subjects known or suspected to have (family) history of malignant hyperthermia 7. Subjects known or suspected to have an allergy to opioids, cyclodextrines (including sugammadex), muscle relaxants or other medication used during general anesthesia 8. Female subjects who are pregnant (pregnancy will be excluded for women both from medical history and by an hCG test within 24 h before surgery, except for women who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or a hysterectomy) 9. Female subjects who are breast-feeding 10. Subjects who have already participated in a previous trial with sugammadex, including Trial 19.4.316 11. Subjects who have participated in another inventional trial within 30 days of entering into 19.4.316
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E.5 End points |
E.5.1 | Primary end point(s) |
Time from start of administration of sugammadex/placebo to the recovery of T4/T1 ratio to 0.9. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |