Administration of dexamethasone during surgery in day-case gynaecological surgery and its impact on sleep quality in the period following surgery.

• Conditions: Postoperative sleep quality; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-003358-15-IE
• Lead Sponsor: James Martin Shannon, MB Bch NUI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-10
• Last Update Posted: 26 October 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of a single intraoperative intravenous dose of 8 mg of dexamethasone on sleep quality in the postoperative period.;Secondary Objective: Not applicable.;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.;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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.