E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with IBD, between 18 and 65 years, which are scheduled for a colonoscopy with PSA. |
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E.1.1.1 | Medical condition in easily understood language |
patients with IBD, between 18 and 65 years, which are scheduled for a colonoscopy with PSA. |
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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 |
te evaluate whether continuous infusion of lidocaïne reduces the need for alfentanyl in diagnostic colonoscopy in patients with Crohn disease or ulcerative colitis. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the differences in side effects like respiratory depression, hypotension, postoperative nausea and vomiting (PONV) and post procedural pain between placebo and intravenous lidocaïne. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Colonoscopy performed under PSA
Age 18-65 years
Inflammatory bowel disease: Crohn’s disease or ulcerative colitis
Informed consent
ASA classification 1 or 2
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E.4 | Principal exclusion criteria |
Pregnancy.
Emergency colonoscopy.
Known allergies for study medication
Known rhythm disorders i.e. second or third degree AV block
BMI >35
Obstructive sleep apnea syndrome
Uncontrolled hypertension
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this study is to evaluate whether intravenously lidocaine reduces the need for alfentanyl during colonoscopy in patients with IBD |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Incidence of hypotension (a mean arterial pressure (MAP < 60 mmHg), is recorded as an adverse event if an intervention is performed to improve the blood pressure.
These interventions include administration of:
- IV Fluid challenge
- Medications
Incidence of oxygen desaturation (<92%), is recorded as an adverse event if an intervention is performed to improve the oxygen saturation.
These interventions include the following:
- Vigorous tactile stimulation
- Airway repositioning
- Suctioning
- Increased oxygen delivery
- Oral or nasal airway placement
- Application of positive pressure or ventilation with bag mask
Incidence of unpleasant recall of the procedure.
Postprocedural NRS
Incidence of PONV
Incidence of adverse effects of lidocaine:
light headedness, tinnitus, dizziness, blurred vision or double vision, metal taste.
Total propofol dose
Colonoscopy time
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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 | 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 | 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 | Yes |
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
|
the end point of te trial is after te last patient has fully undergone the colonoscopy and is discharged. |
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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 |