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Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery

Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07550803
Enrollment
102
Registered
2026-04-24
Start date
2026-06-01
Completion date
2027-07-01
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disturbance

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.

Interventions

DRUGDexamethasone

Dexamethasone 10 mg will be administered intravenously during induction of general anesthesia. This single-dose corticosteroid is used for its anti-inflammatory and antiemetic effects. All other perioperative management will be conducted according to standard institutional protocols and will be identical to the control group

DRUGNormal Saline

normal saline 2cc will be administered intravenously during induction of general anesthesia.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Richards-Campbell Sleep Questionnaire (RCSQ) scoreon postoperative day 1Sleep 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

MeasureTime frameDescription
Quality of Recovery-15 (QoR-15) scorePostoperative day 1Overall postoperative recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a validated patient-reported outcome measure. Higher scores indicate better recovery. The total score ranges from 0 to 150, with higher scores indicating better recovery.
sleep efficiencyPostoperative night (day of surgery)sleep efficiency (%) during the postoperative night (day of surgery), measured using a wearable device.
Incidence of postoperative nausea and vomitingFrom end of surgery to postoperative day 1Incidence and severity of postoperative nausea and vomiting assessed using a 4-point scale, and use of rescue antiemetics. 0 = no nausea or vomiting, 1. = mild nausea, 2. = moderate nausea, 3. = severe nausea or vomiting. Higher scores indicate worse symptoms.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026