E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We intend to investigate the anxiolytic effects of melatonin in relation to surgery. |
Vi vil undersøge effekten af melatonin på angst i relation til kirurgi. |
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E.1.1.1 | Medical condition in easily understood language |
We intend to investigate the anxiolytic effects of melatonin in relation to surgery. |
Vi vil undersøge effekten af melatonin på angst i relation til kirurgi. |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002855 |
E.1.2 | Term | Anxiety |
E.1.2 | System Organ Class | 10037175 - Psychiatric 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 |
This study's main objective is to investigate melatonins anxiolytic effects in surgical patients (inguinal or umbilical hernia). |
Studiets formål er at undersøge de angstdæmpende effekter af melatonin ved operationspatienter (lyske- eller navlebrok). |
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E.2.2 | Secondary objectives of the trial |
Quality of sleep and general well-being. |
Søvnkvalitet og generel velbefindende |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who are candidates for inguinal or umbilical hernia repair
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Patienter, der er kandidat til operation for lyske- eller navlebrok.
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E.4 | Principal exclusion criteria |
Patients, who use daily opioids, benzodiazepines or melatonin Patients diagnosed with a psychiatric disorder (defined as in medical treatment) Patients with severe physical disease (ASA 3-4)
Patients with previous or ongoing alcohol or drug abuse
Patients with liver disease (defined as in medical treatment) Patients diagnosed sleep disturbances Patients who are unable to cooperate according to the protocol Patients with allergy to melatonin
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Patienter i daglig behandling med opioder, benzodiazepiner eller melatonin Patienter, der er diagnosticeret med psykiatrisk lidelse (defineret ved igangværende medicinsk behandling) Patienter med svær fysisk sygdom (ASA 4). Patienter med aktivt eller tidligere alkohol- eller stofmisbrug Patienter med kendt leverlidelse (defineret ved igangværende medicinsk behandling) Patienter diagnosticeret med søvnforstyrrelse Patienter, der er ude af stand til at samarbejde i henhold til forsøgsprotokollen Allergi overfor melatonin
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E.5 End points |
E.5.1 | Primary end point(s) |
Pre-operative anxiety (60 minutes before surgery) measured using the State-Trait Anxiety Index (STAI)
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Præoperativ angst (60 min før operation) målt via the State-Trait Anxiety Index
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
STAI is measured at the preoperative interview, 60 minutes before surgery and 4 hours postoperatively. |
STAI: måles ved den præoperative samtale, 60 minutter præoperativ og 4 timer postoperativt |
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E.5.2 | Secondary end point(s) |
Postoperative anxiety (STAI) Pre- and postoperativ anxiety (VAS) Intraoperative use of remifentanil Intraoperative use of propofol Use of rescue-opioids on the ward Use of rescue-opioids in the perioperative section Perioperative sleep quality General well-being, and the degree og fatigue Time hospitalized Plasma concentrations of melatonin |
Postoperativ angst (STAI) Intraoperativ forbrug af remifentanil Intraoperativ forbrug af propofol Forbrug af rescue-opioid i det perioperative afsnit Forbrug af rescue-opioid på stamafdelingen Perioperativ søvnkvalitet Generel velbefindende og graden af udmattethed Total indlæggelsestid Plasma koncentrationer af melatonin |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Pre- and postoperative anxiety (stai): at the preoperative interview, 60 minutes prior to surgery and 4 hours postoperatively. Pre- and postoperative anxiety (VAS): at the preoperative interview, 60 minutes prior to surgery and 1,2 and 4 hours postoperatively.
Perioperative sleep quality: the morning before surgery and the morning after surgery. General well-being and the degree of fatigue: the morning before surgery and the morning after surgery.
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Præ- og perioperativ angst (STAI): præoperative samtale, 60 min. inden operation og 4 timer postoperativt. Præ- og perioperativ angst (VAS): præoperative samtale, 60 min. inden operation og 1,2 og 4 timer postoperativt. Perioperativ søvnkvalitet: morgenen inden operation og morgenen efter operation. Generel velbefindende og graden af udmattethed: morgenen inden operation og morgenen efter operation.
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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
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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 | |