Health TrialsbyHealthPanel

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

ConditionSleep Disturbance
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 19 years or older undergoing nasal surgery.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: dexamethasoneExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
on postoperative day 1

Secondary outcomes

1

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
2

sleep efficiency

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

Time frame
Postoperative night (day of surgery)
3

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: