E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative sleep quality |
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E.1.1.1 | Medical condition in easily understood language |
Sleep quality following surgery |
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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 determine the effect of a single intraoperative intravenous dose of 8 mg of dexamethasone on sleep quality in the postoperative period. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must be able and willing to give written informed consent and to comply with the requirements of the study protocol. Subjects must be female, aged 18 years or above. Subjects must be scheduled to undergo uterine dilation and curettage with or without hysteroscopy. Subjects must be judged to be in generally good health to undergo surgery based upon the results of the medical history, laboratory tests, physical examination, and +/- CXR and 12-lead electrocardiogram, performed during pre-assessment.
Subjects’ urine pregnancy test performed at pre-assessment must be negative. Subjects’ baseline PSQI score must be <6. Subjects must have clinically acceptable preoperative renal and hepatic function tests and a random blood glucose level between 4.4 - 7.8 mmol/l. Subjects must achieve satisfactory postoperative analgaesia with paracetamol and non- steroidal anti-inflammatory drugs (NSAIDs). |
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E.4 | Principal exclusion criteria |
Allergy/ sensitivity to dexamethasone. Patients younger than 18 years of age. Female subjects who are pregnant or breast-feeding at the time of surgery. Subjects unable to provide written informed consent. Subjects’ baseline PSQI score ≥6. Subjects who are chronic steroid users, as this may influence the result of the study. Subjects who have significant renal or hepatic impairment in preoperative laboratory tests that may influence the result of the study. Subjects who are known to suffer from diabetes mellitus or have an abnormal preoperative random blood glucose test, as it may put the subject at risk of hypoglycaemia. Subjects who require opioids for analgaesia in the postoperative period. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine the effect of a single intraoperative intravenous dose of 8 mg of dexamethasone on sleep quality in the postoperative period. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
All patients will undergo a baseline Pittsburgh Sleep Quality Index (PSQI) assessment. The PSQI is a highly validated self- assessment tool that effectively measures the quality and patterns of sleep in the adult. Patients will be followed up one week after operation via a telephone interview and a blinded interviewer will repeat the PSQI. |
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E.5.2 | Secondary end point(s) |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Non-administration of drug |
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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
| 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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Last postoperative phone contact of the last subject enrolled in 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 | 6 |
E.8.9.1 | In the Member State concerned days | |