Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 102
- Primary Endpoint
- Richards-Campbell Sleep Questionnaire (RCSQ) score
Overview
Brief Summary
This study aims to evaluate the effect of intraoperative dexamethasone on early postoperative sleep quality in adult patients undergoing nasal surgery under general anesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 19 years or older undergoing nasal surgery.
Exclusion Criteria
- •Patients who do not provide informed consent
- •Patients with neurological disease or cognitive impairment that may interfere with questionnaire completion
- •Patients with pre-existing sleep disorders or those taking sleep medications
- •Patients receiving chronic corticosteroid therapy
- •Known hypersensitivity to dexamethasone
- •Patients with glaucoma
- •Patients with poorly controlled diabetes mellitus (HbA1c \> 8.0%)
- •Patients with peptic ulcer disease
- •Pregnant or breastfeeding women
- •Patients deemed unsuitable for the study by the investigator (e.g., those requiring postoperative steroid administration for clinical reasons)
Arms & Interventions
dexamethasone
Participants in this group will receive intravenous dexamethasone 10 mg during induction of general anesthesia. All other perioperative management, including anesthetic technique and postoperative care, will be conducted according to standard institutional protocols and will be identical to the control group.
Intervention: Dexamethasone (Drug)
placebo
Participants in this group will receive intravenous normal saline (2 mL) during induction of general anesthesia as a placebo. All other perioperative management, including anesthetic technique and postoperative care, will be identical to the experimental group.
Intervention: Normal Saline (Drug)
Outcomes
Primary Outcomes
Richards-Campbell Sleep Questionnaire (RCSQ) score
Time Frame: on postoperative day 1
Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated patient-reported outcome measure. The RCSQ consists of five items evaluating depth of sleep, sleep latency, number of awakenings, efficiency of sleep, and overall sleep quality. Each item is scored on a visual analog scale from 0 to 100, with higher scores indicating better sleep quality.
Secondary Outcomes
- Quality of Recovery-15 (QoR-15) score(Postoperative day 1)
- sleep efficiency(Postoperative night (day of surgery))
- Incidence of postoperative nausea and vomiting(From end of surgery to postoperative day 1)
Investigators
Shin Kyung Won, MD
Doctor
Seoul National University Hospital