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

NCT07550803 | Not Yet Recruiting

• 1 other identifier: 2601-116-1712
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

dexamethasone

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

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

dexamethasone

Normal Saline DRUG

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

placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older undergoing nasal surgery.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Parasomnias

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04