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

N/ANot Yet RecruitingNCT07550803

Seoul National University Hospital102 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

102

Conditions

Sleep Disturbance

Interventions

DexamethasoneDRUG

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 SalineDRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: on postoperative day 1

Secondary Outcomes

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.

Time frame: Postoperative day 1

sleep efficiency

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

Time frame: 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, 1. = mild nausea, 2. = moderate nausea, 3. = severe nausea or vomiting. Higher scores indicate worse symptoms.

Time frame: From end of surgery to postoperative day 1

Data from ClinicalTrials.gov

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