Septal DeviationNCT07416773
Anesthesia Technique and Postoperative Sleep Quality After Septoplasty
An observational study of Septal Deviation and Postoperative Sleep Quality, run by Sevim Şenol Karataş at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the relationship between anesthesia type and postoperative sleep quality in adult patients undergoing septoplasty. Patients will receive either total intravenous anesthesia or inhalational anesthesia as part of routine clinical care, without any intervention or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septal Deviation, Postoperative Sleep Quality, Anesthesia Techniques
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 15 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 years and older who undergo elective septoplasty at Elazig Fethi Sekin City Hospital. Eligible participants are classified as American Society of Anesthesiologists (ASA) physical status I-III and receive either total intravenous anesthesia or inhalational anesthesia as part of routine clinical care. Patients are enrolled consecutively after providing written informed consent, and no intervention or modification to standard anesthetic or postoperative management is performed as part of the study.
Who may be able to join
- • American Society of Anesthesiologists (ASA) Class I-III
- Patients aged 18 and over
- Those who provided written informed consent at the preoperative anesthesia clinic and allowed telephone follow-up on days 2/8.
Who cannot join
- • ASA Class IV and V
- Patients under 18 years of age
- Treatment of severe sleep disorders: Those with severe OSA confirmed by polysomnography and using active CPAP therapy. • Significant cognitive impairment, delirium, active psychotic disorder that prevents reliable completion of scales. • Regular use of hypnotics/benzodiazepines, sedatives/antipsychotics, or chronic opioids (≥3 days/week in the last month), alcohol or substance abuse. • Perioperative complications: Major complications during surgery, unplanned need for intensive care, or reoperation within the first 24 hours. • Pregnancy or breastfeeding. • Severe systemic disease, unstable cardiopulmonary status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Anesthesia Type and Postoperative Sleep Quality in Patients Undergoing Septoplasty: A Prospective Observational Study
This prospective observational study aims to evaluate the relationship between anesthesia type and postoperative sleep quality in adult patients undergoing septoplasty. Patients will receive either total intravenous anesthesia or inhalational anesthesia as part of routine clinical care, without any intervention or modification to standard practice. Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire on postoperative days 7 and 15 through structured telephone interviews. Secondary outcomes include postoperative pain intensity, opioid consumption, and postoperative nausea and vomiting. The study seeks to provide real-world evidence on the association between anesthetic approach and posto
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total Intravenous Anesthesia (TIVA) | Not described | |
| Inhalational Anesthesia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richards-Campbell Sleep Questionnaire (RCSQ) Total Score
Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire. The total RCSQ score is calculated as the mean of five items scored on a 0-100 visual analog scale, with higher scores indicating better sleep quality.
Measured: Postoperative day 7 and postoperative day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Nov 2025
- Primary completion10 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septal DeviationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sevim Şenol Karataş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416773
- Sponsor's protocol ID
- SEPTUM-ANESTH-SLEEP-2025
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Evaluation of the Relationship Between Anesthesia Type and Postoperative Sleep Quality in Patients Undergoing Septoplasty: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07416773
- Acronym / sponsor ID
- SEPTUM-ANESTH-SLEEP-2025
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sevim Şenol KarataşUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 18 Feb 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 prospective observational study aims to evaluate the relationship between anesthesia type and postoperative sleep quality in adult patients undergoing septoplasty. Patients will receive either total intravenous anesthesia or inhalational anesthesia as part of routine clinical care, without any intervention or modification to standard practice. Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire on postoperative days 7 and 15 through structured telephone interviews. Secondary outcomes include postoperative pain intensity, opioid consumption, and postoperative nausea and vomiting. The study seeks to provide real-world evidence on the association between anesthetic approach and posto
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous Anesthesia (TIVA) | – | – |
| Inhalational Anesthesia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years and older who undergo elective septoplasty at Elazig Fethi Sekin City Hospital. Eligible participants are classified as American Society of Anesthesiologists (ASA) physical status I-III and receive either total intravenous anesthesia or inhalational anesthesia as part of routine clinical care. Patients are enrolled consecutively after providing written informed consent, and no intervention or modification to standard anesthetic or postoperative management is performed as part of the study.
Key inclusion criteria (3 listed)
- • American Society of Anesthesiologists (ASA) Class I-III
Key exclusion criteria (3 listed)
- • ASA Class IV and V
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Richards-Campbell Sleep Questionnaire (RCSQ) Total Score
Time frame: Postoperative day 7 and postoperative day 15
Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire. The total RCSQ score is calculated as the mean of five items scored on a 0-100 visual analog scale, with higher scores indicating better sleep quality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septal Deviation and Postoperative Sleep Quality, run by Sevim Şenol Karataş at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, 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.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) Total Score (time frame: Postoperative day 7 and postoperative day 15). 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.