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

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 Overview

• Status: Not yet recruiting
• Conditions: Sleep Disturbance
• Intervention / Treatment: Drug: Dexamethasone; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Dexamethasone; 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
Placebo Comparator: 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.	Drug: Normal Saline; normal saline 2cc will be administered intravenously during induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Richards-Campbell Sleep Questionnaire (RCSQ) score	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.	on postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-15 (QoR-15) score	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.	Postoperative day 1
sleep efficiency	sleep efficiency (%) during the postoperative night (day of surgery), measured using a wearable device.	Postoperative night (day of surgery)
Incidence of postoperative nausea and vomiting	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.	From end of surgery to postoperative day 1

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias; Pharmaceutical Preparations; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pregnadienetriols; Dexamethasone; Saline Solution
• Other Study ID Numbers: 2601-116-1712

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No