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NCT Number: NCT07550803

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

This study aims to evaluate the effect of intraoperative dexamethasone on early postoperative sleep quality in adult patients undergoing nasal surgery under general anesthesia.

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Key information

Conditions

Sleep Disturbance Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexamethasone

Drug

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

normal saline

Drug

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

Primary outcomes

  1. 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

  1. Quality of Recovery-15 (QoR-15) score

    Time frame: Postoperative day 1

    Overall 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.

  2. sleep efficiency

    Time frame: Postoperative night (day of surgery)

    sleep efficiency (%) during the postoperative night (day of surgery), measured using a wearable device.

  3. Incidence of postoperative nausea and vomiting

    Time frame: From end of surgery to postoperative day 1

    Incidence and severity of postoperative nausea and vomiting assessed using a 4-point scale, and use of rescue antiemetics.

    0 = no nausea or vomiting,

    • = mild nausea,
    • = moderate nausea,
    • = severe nausea or vomiting. Higher scores indicate worse symptoms.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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