Postoperative sleep quality
Conditions
Interventions
Trade Name: Dexamethasone Phosphate
Product Name: Dexamethasone Phosphate
Product Code: PA0437/014/002
Pharmaceutical Form: Solution for injection
Sponsors
James Martin Shannon, MB Bch NUI
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Ireland
Contacts
Public ContactJoao Marques Vinagre
Joao Marques Vinagre
Outcome results
None listed