Postoperative Sleep QualityANES-SLEEPNCT07325799
Anesthesia Type and Postoperative Sleep Quality in Septoplasty
An observational study of Postoperative Sleep Quality and Nasal Septum Deviation, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the association between routinely applied anesthesia techniques and postoperative sleep quality in adult patients undergoing septoplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Sleep Quality, Nasal Septum Deviation, Septoplasty
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 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 will consist of adult patients aged 18 years and older who are scheduled to undergo elective septoplasty under general anesthesia. Patients will receive either total intravenous anesthesia or inhalational anesthesia according to routine clinical practice. Only patients who provide written informed consent and agree to postoperative follow-up assessments will be included. The study population will be recruited from a single tertiary care hospital.
Who may be able to join
- - Adults aged 18 years and older
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective septoplasty under general anesthesia
- Willing and able to provide written informed consent
- Agree to postoperative follow-up telephone interviews on postoperative days 7 and 15
Who cannot join
- - ASA physical status IV or V
- Age younger than 18 years
- Severe obstructive sleep apnea confirmed by polysomnography and requiring active CPAP therapy
- Significant cognitive impairment, delirium, or active psychiatric disorder preventing reliable questionnaire completion
- Chronic use of opioids, benzodiazepines, hypnotics, sedatives, or antipsychotic medications (≥3 days per week within the last month)
- Alcohol or substance abuse
Show all 9Show fewer
- Major intraoperative complications, unplanned intensive care unit admission, or reoperation within the first 24 hours
- Pregnancy or breastfeeding
- Severe systemic disease or unstable cardiopulmonary condition
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Merkez, 23200
About this study
Official title: Evaluation of the Association Between Anesthesia Type and Postoperative Sleep Quality in Septoplasty Patients: A Prospective Observational Study
This prospective observational study aims to evaluate the association between routinely applied anesthesia techniques and postoperative sleep quality in adult patients undergoing septoplasty. Patients will receive either total intravenous anesthesia or inhalational anesthesia according to standard clinical practice, without any intervention by the investigators. Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire on postoperative days 7 and 15. Secondary outcomes include postoperative pain intensity, opioid consumption, and postoperative nausea and vomiting.
Read the detailed description
This study is designed as a prospective, observational cohort study conducted at a single tertiary care center. The study population will consist of adult patients undergoing elective septoplasty for nasal septum deviation. All patients will receive general anesthesia as part of routine clinical care, either using total intravenous anesthesia (TIVA) or inhalational anesthesia, according to the anesthesiologist's standard practice. No randomization or study-related intervention will be performed.
Eligible patients will be enrolled consecutively after providing written informed consent. Demographic data, clinical characteristics, American Society of Anesthesiologists (ASA) physical status, duration of surgery, anesthesia technique, perioperative opioid consumption, and postoperative complications will be recorded prospectively using hospital electronic medical records and standardized case report forms.
Postoperative sleep quality will be evaluated using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated patient-reported outcome measure. Follow-up assessments will be conducted via telephone interviews on postoperative days 7 and 15. Pain intensity will be assessed using the Numerical Pain Rating Scale, and postoperative nausea and vomiting will be evaluated using a standardized ordinal scale.
- Conditions
- Postoperative Sleep Quality, Nasal Septum Deviation, Septoplasty, Total Intravenous Anesthesia, Inhalational Anesthesia
- Keywords
- Total Intravenous Anesthesia, Inhalational Anesthesia, Postoperative Sleep Quality, Richards-Campbell Sleep Questionnaire, Septoplasty
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 | Patients receiving total intravenous anesthesia as part of routine clinical practice. | |
| Inhalational Anesthesia | Patients receiving inhalational general anesthesia according to routine clinical practice. |
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 (RCSQ).
The total RCSQ score ranges from 0 to 100 and is calculated as the mean of five core items.
Higher scores indicate better sleep quality.
Measured: Postoperative day 7 and postoperative day 15
Secondary outcomes (1)
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Numerical Pain Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain).
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 posted8 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Why it stopped: This record is a duplicate entry created in error. The correct study is registered under NCT07416773. The study was never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Sleep QualityStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325799
- Sponsor's protocol ID
- FSH-ANES-SEP-SLEEP-2025
- Acronym
- ANES-SLEEP
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
PubMed 11227580Lin D, Huang X, Sun Y, Wei C, Wu A. Perioperative Sleep Disorder: A Review. Front Med (Lausanne). 2021 Jun 7;8:640416. doi: 10.3389/fmed.2021.640416. eCollection 2021.
PubMed 34164409Li S, Song B, Li Y, Zhu J. Effects of Intravenous Anesthetics vs Inhaled Anesthetics on Early Postoperative Sleep Quality and Complications of Patients After Laparoscopic Surgery Under General Anesthesia. Nat Sci Sleep. 2021 Mar 15;13:375-382. doi: 10.2147/NSS.S300803. eCollection 2021.
PubMed 33758567
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 Association Between Anesthesia Type and Postoperative Sleep Quality in Septoplasty Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07325799
- Acronym / sponsor ID
- ANES-SLEEP / FSH-ANES-SEP-SLEEP-2025
- Conditions
- Postoperative Sleep Quality, Nasal Septum Deviation, Septoplasty, Total Intravenous Anesthesia, Inhalational Anesthesia
- Keywords
- Total Intravenous Anesthesia, Inhalational Anesthesia, Postoperative Sleep Quality, Richards-Campbell Sleep Questionnaire, Septoplasty
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This record is a duplicate entry created in error. The correct study is registered under NCT07416773. The study was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 8 Jan 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 association between routinely applied anesthesia techniques and postoperative sleep quality in adult patients undergoing septoplasty. Patients will receive either total intravenous anesthesia or inhalational anesthesia according to standard clinical practice, without any intervention by the investigators. Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire on postoperative days 7 and 15. Secondary outcomes include postoperative pain intensity, opioid consumption, and postoperative nausea and vomiting.
Detailed description
This study is designed as a prospective, observational cohort study conducted at a single tertiary care center. The study population will consist of adult patients undergoing elective septoplasty for nasal septum deviation. All patients will receive general anesthesia as part of routine clinical care, either using total intravenous anesthesia (TIVA) or inhalational anesthesia, according to the anesthesiologist's standard practice. No randomization or study-related intervention will be performed.
Eligible patients will be enrolled consecutively after providing written informed consent. Demographic data, clinical characteristics, American Society of Anesthesiologists (ASA) physical status, duration of surgery, anesthesia technique, perioperative opioid consumption, and postoperative complications will be recorded prospectively using hospital electronic medical records and standardized case report forms.
Postoperative sleep quality will be evaluated using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated patient-reported outcome measure. Follow-up assessments will be conducted via telephone interviews on postoperative days 7 and 15. Pain intensity will be assessed using the Numerical Pain Rating Scale, and postoperative nausea and vomiting will be evaluated using a standardized ordinal scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous Anesthesia | – | –Patients receiving total intravenous anesthesia as part of routine clinical practice. |
| Inhalational Anesthesia | – | –Patients receiving inhalational general anesthesia according to routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18 years and older who are scheduled to undergo elective septoplasty under general anesthesia. Patients will receive either total intravenous anesthesia or inhalational anesthesia according to routine clinical practice. Only patients who provide written informed consent and agree to postoperative follow-up assessments will be included. The study population will be recruited from a single tertiary care hospital.
Key inclusion criteria (5 listed)
- - Adults aged 18 years and older
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective septoplasty under general anesthesia
- Willing and able to provide written informed consent
- Agree to postoperative follow-up telephone interviews on postoperative days 7 and 15
Key exclusion criteria (9 listed)
- - ASA physical status IV or V
- Age younger than 18 years
- Severe obstructive sleep apnea confirmed by polysomnography and requiring active CPAP therapy
- Significant cognitive impairment, delirium, or active psychiatric disorder preventing reliable questionnaire completion
- Chronic use of opioids, benzodiazepines, hypnotics, sedatives, or antipsychotic medications (≥3 days per week within the last month)
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 (RCSQ). The total RCSQ score ranges from 0 to 100 and is calculated as the mean of five core items. Higher scores indicate better sleep quality.
1 secondary outcome
Postoperative Pain Intensity
Time frame: Postoperative day 7 and postoperative day 15
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 11227580Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
- Background: PubMed 34164409Lin D, Huang X, Sun Y, Wei C, Wu A. Perioperative Sleep Disorder: A Review. Front Med (Lausanne). 2021 Jun 7;8:640416. doi: 10.3389/fmed.2021.640416. eCollection 2021.
- Background: PubMed 33758567Li S, Song B, Li Y, Zhu J. Effects of Intravenous Anesthetics vs Inhaled Anesthetics on Early Postoperative Sleep Quality and Complications of Patients After Laparoscopic Surgery Under General Anesthesia. Nat Sci Sleep. 2021 Mar 15;13:375-382. doi: 10.2147/NSS.S300803. eCollection 2021.
- 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 Postoperative Sleep Quality and Nasal Septum Deviation, run by Elazıg Fethi Sekin Sehir Hastanesi 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 5 inclusion and 9 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.
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?
On the ClinicalTrials.gov record for NCT07325799, which also lists 3 linked publications.
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.