Sleep DisturbanceNCT07550803
Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery
A study testing Dexamethasone and Normal Saline in people with Sleep Disturbance, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Dexamethasone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older undergoing nasal surgery.
Who cannot join
- 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
Show all 10Show fewer
- 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)
About this study
Official title: 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.
- Conditions
- Sleep Disturbance
- Being tested
- Dexamethasone, Normal Saline
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: on postoperative day 1
Secondary outcomes (3)
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.
Measured: Postoperative day 1
sleep efficiency
sleep efficiency (%) during the postoperative night (day of surgery), measured using a wearable device.
Measured: 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.
Measured: From end of surgery to postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shin Kyung Won, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550803
- Sponsor's protocol ID
- 2601-116-1712
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07550803
- Acronym / sponsor ID
- 2601-116-1712
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | Experimental | Drug: DexamethasoneParticipants 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. |
| placebo | Placebo comparator | Drug: Normal SalineParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 19 years or older undergoing nasal surgery.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDexamethasone 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 | Drug | dexamethasone |
| Normal Salinenormal saline 2cc will be administered intravenously during induction of general anesthesia. | Drug | placebo |
Primary outcome
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.
3 secondary outcomes
Quality of Recovery-15 (QoR-15) score
Time frame: Postoperative day 1
sleep efficiency
Time frame: Postoperative night (day of surgery)
Incidence of postoperative nausea and vomiting
Time frame: From end of surgery to postoperative day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Normal Saline in people with Sleep Disturbance, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richards-Campbell Sleep Questionnaire (RCSQ) score (time frame: on postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.