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 show the time to recovery from a neuromuscular blockade induced by rocuronium after reversal at 1-2 PTC by 4.0 mg.kg-1 sugammadex is within ten minutes in 95% of Chinese subjects undergoing elective surgery during profound neuromuscular blockade under propofol anesthesia. |
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E.2.2 | Secondary objectives of the trial |
- to show the time to recovery from a neuromuscular blockade induced by rocuronium after reversal at 1-2 PTC by 4.0 mg.kg-1 sugammadex is within ten minutes in 95% of Caucasian subjects undergoing elective surgery during profound neuromuscular blockade under propofol anesthesia; − to show equivalence in the time to recovery from rocuronium induced NMB after reversal at 1-2 PTC by 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects undergoing elective surgery during profound neuromuscular blockade under propofol anesthesia; − to evaluate the safety of 4.0 mg.kg-1 sugammadex in subjects undergoing elective surgery during profound neuromuscular blockade under propofol anesthesia; − to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay in subjects with rocuronium induced neuromuscular blockade reversed by 4.0 mg.kg-1 sugammadex at 1-2 PTC. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female subjects: 1. of ASA class 1-3 (extremes included) 2. of age between 18 - 64 years (extremes included) 3. who are scheduled for elective surgery under general anesthesia in the supine position, which requires profound neuromuscular blockade using an NMBA 4. have given written informed consent 5. For China only: who are of the Chinese race, i.e. Chinese descent born in China, never immigrated out of China and have a Chinese home address 6. For Europe only: who are of the Caucasian race, i.e. Caucasian descent born in Europe, never immigrated out of Europe and have a European home address |
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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 suspected to have neuromuscular disorders affecting NMB 3. Subjects known or suspected to have a significant renal or hepatic dysfunction 4. Subjects known or suspected to have (family) history of malignant hyperthermia 5. Subjects known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia 6. Subjects receiving or for whom it is planned to adminster medication expected to interfere with the effect of rocuronium as given in this trial, based on the dose and the time of administration, such as antibiotics, anticonvulsants and Mg 2+ (Note, Chinese herbal medicines are allowed) 7. 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) 8. Female subjects who are breast-feeding 9. Subjects who have already participated in a previous trial with sugammadex 10. Subjects who participated in another clinical trial not pre-approved by NV Organon, within 30 days of entering into trial 19.4.335 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The time from start of administration of sugammadex to recovery of the 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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |