E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038678 |
E.1.2 | Term | Respiratory depression |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 |
A reduction in the incidence of respiratory depression in patients who have received intrathecal morphine as part of their analgesic regimen for major hepatobiliary surgery. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are effect on analgesia, supplemental fentanyl administration, rates of nausea and vomiting, sedation scores, pruritus and any adverse outcomes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients >18 years of age • Capable of giving informed consent. • Undergoing elective open hepatic resection, pancreatectomy or partial pancreatectomy, or other open major hepatobiliary surgery in St Vincents University Hospital. • Consenting to standard anaesthetic and analgesic regimen in the hepatobiliary unit.
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E.4 | Principal exclusion criteria |
• Chronic opioid use • Pregnancy • <18 years of age • Major Psychiatric illness • Epilepsy with recent seizures • Personal history of adverse reaction to naloxone or any of its derivatives • Contraindication to neuraxial injection • Obstructive sleep apnoea |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Respiratory depression will be diagnosed based on a composite clinical opinion based on a set of criteria which incorporates some of the clinical criteria used and the ASA prevention of respiratory depression guidance document. - Respiratory rate < 10 / min - SpO2 < 92% or an increase in supplemental O2 Arterial blood gases will be taken 2 hourly while patients are in PACU / HDU and assessed on site as is standard practice.
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E.5.2 | Secondary end point(s) |
Measure occurrence of: 1. Pain 2. Requirement for rescue analgesia 3. Nausea/Vomiting 4. Pruritus
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Pain Scores will be recorded hourly using a verbal rating scale of 0-10. Presence/absence of occurrence of other endpoints will be evaluated at time of occurrence. |
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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 | Yes |
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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |