E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing surgery at the Erasmus Medical Centre Rotterdam in a
period from January 2018 till the end of inclusion.
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E.1.1.1 | Medical condition in easily understood language |
Patients undergoing surgery at the Erasmus Medical Centre Rotterdam in a
period from January 2018 till the end of inclusion.
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the effect on the distention of the ONSD while using lidocaine 1,5 mg/kg IV during endotracheal intubation versus placebo. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to investigate the effect size of lidocaine 1,5 mg/kg IV |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients aged >18 year old, ASA I or II, scheduled for elective surgery under general anesthesia with a planned duration of the procedure > 30 min that can be routinely performed with a ETI. |
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Surgery of the eye an eye region
- Bilateral eye trauma
- Glaucoma
- Mentally retarded patients
- Contraindications for the use of lidocaine e.g.
o Heart block, second or third degree (without pacemaker)
o Severe sinoatrial block (without pacemaker)
o Serious adverse drug reaction to lidocaine or amide local anesthetics
o Concurrent treatment with quinidine, flecainide, disopyramide, procainamide (class I antiarrhythmic agents)
o Prior use of amiodarone hydrochloride
o Adams-Stokes syndrome (ASS)
o Wolff-Parkinson-White syndrome (WPW)
o Severe heart failure
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in optic nerve sheet diameter in millimetre before, during and after intubation between both groups. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
before, during and after intubation between both groups. |
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E.5.2 | Secondary end point(s) |
Time taken for the ONSD to return back to its initial value once the patients is
intubated
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |