E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim of this study is to determine the proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years. |
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E.1.1.1 | Medical condition in easily understood language |
The aim of this study is to determine the proportion of excellent tracheal intubation conditions after administration of either rocuronium or suxamethonium in patients with age ≥ 80 years. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051079 |
E.1.2 | Term | Orthopedic procedure |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000082 |
E.1.2 | Term | Abdominal pain generalised |
E.1.2 | System Organ Class | 100000004856 |
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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 aim of this study is to determine the proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years. |
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E.2.2 | Secondary objectives of the trial |
The aim of this study is to determine the proportion of excellent tracheal intubation conditions administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥ 80 - Scheduled for surgery under general anesthesia with indication for rapid sequence induction - American Society of Anesthesiologists physical status classification (ASA) I to IV - Informed consent (see appendix 1) - Body mass index (BMI) < 35 kg/m2 - Read and understand Danish
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E.4 | Principal exclusion criteria |
- Neuromuscular disease - Known allergy to rocuronium and/or suxamethonium - Known hyperkalemia > 5 mM - Previous malignant hyperthermia - Known homozygote plasmacholinesterase gene mutation variant a or s - Known impaired kidney function defined as estimated glomerular filtration rate (eGFR) < 30
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is the proportion with excellent intubation conditions during the first attempt to intubate employing the Fuchs-Buder rating scale 60 seconds after administration of 1.0 mg/kg rocuronium or 1.0 mg/kg succinylcholine. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Examined during induction of anaesthesia |
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E.5.2 | Secondary end point(s) |
• Time to tracheal intubation (from administration of muscle relaxant till correct placement of tracheal tube) • First pass success rate • Time to TOF 0 • Intubation conditions (IDS) • Occurrence of desaturation ≤ 90% (yes/no, from administration of NMBA until tracheal intubation). • Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes from administration of NMBA) • Occurrence of hoarseness and sore throat within 24 hours postoperatively • Occurrence of muscle soreness postoperatively (<24 hours) and if so at postoperative day 3
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Within 24 hours postoperatively |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
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 | No |
E.8.2.3.1 | Comparator description |
comparison of suxamethonium 1 mg/kg with rocuronium 1 mg/kg |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
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 | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |