E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Males and females in the age of 18-65 undergoing minor surgery/gynaecological procedures with a medical need for general anesthesia and neuromuscular blockade will be included in the study. |
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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 |
The main aim of the present study is i)To assess whether sugammadex has a positive effect on the post-operative alertness of the patients, and ii) to assess the nature, magnitude and the time of onset of this effect (if any). |
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E.2.2 | Secondary objectives of the trial |
To assess the nature, magnitude and the time of onset of this effect (if any). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Males and females. - Age 18-65 years. - Able to perform the study assessments. - ASA classification 1 or 2. - Medical need for general anesthesia and neuromuscular blockade. - NMB with the standard dose of rocuronium. If the surgery lasts longer than 75 minutes the patient will be excluded. - Minor surgical and gynecological procedures that require tracheal intubation and mechanical ventilation. - Signed informed consent. |
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E.4 | Principal exclusion criteria |
- Contra-indications for rocuronium, sugammadex, neostigmine and/or atropine. - Concomitant conditions or diseases that might interfere with the study assessments. - Concomitant treatment with any experimental drug within 4 weeks before surgery.
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E.5 End points |
E.5.1 | Primary end point(s) |
At baseline (1 day before surgery), and 30, 60, and 120 minutes after the TOF ratio of ~0,9 has been reached, the following commonly used, and non-invasive cognitive evaluations/scoring lists will be carried out in a subsequent order to assess recovery and psychomotor function:
Modified Aldrete score The modified Aldrete score (see Appendix 2) assesses the degree of post-anesthesia recovery, based on ability to move extremities, respiration and circulation status, consciousness and oxygen saturation. Each item is scored from 0 (poor) to 2 (good). ≥9 points are needed for recovery to be confirmed, i.e. the patient is ready for discharge from the PACU.
Trail making test This test is used to measure visual conceptual and visual motor tracking 29. Normally, the entire test can be completed in 5 to 10 minutes. Only part A of this test will be performed. Since it is a test of speed, the examiner must stress the importance of time and efficiency. Part A consists of encircled numbers from 1 to 25 randomly spread across a sheet of paper. The object of the test is for the subject to connect the numbers in order, beginning with 1 and ending with 25, in as little time as possible. The number of failures to connect and the distance from the actual line to the number will be determined.
Maddox wing test With the Maddox Wing instrument an imbalance in the extra-ocular muscles of the eyes (degree of strabismus) will be measured, where the field of vision is divided by oblique and vertical wings such that the arrow is seen by the right eye and a numbered scale in prism diopters by the left.
Visual Analogue Scales for patient and observer to rate post-operative alertness and recovery |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
no reversal agent/sponteneous recovery |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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Bridion is registered in the EU since 2008 with a confirmed safety profole and commonly used in daily cllinical practice. Also, except for the assessments of non invasive (cognitive) assessments, the aneasthetic and surgical procedures are according to the usual procedures. Randomization for eligable patients will be stopped when the number of 90 evaluable patients has been reached.
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |