Anesthesia Type and Postoperative Sleep Quality in Septoplasty

NCT ID: NCT07325799

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-03-01

Brief Summary

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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

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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

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Postoperative Sleep Quality Nasal Septum Deviation Septoplasty Total Intravenous Anesthesia Inhalational Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Total Intravenous Anesthesia

Patients receiving total intravenous anesthesia as part of routine clinical practice.

No interventions assigned to this group

Inhalational Anesthesia

Patients receiving inhalational general anesthesia according to routine clinical practice.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* \- 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

Exclusion Criteria

* \- 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elazıg Fethi Sekin Sehir Hastanesi

OTHER

Sponsor Role lead

Responsible Party

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Sevim Şenol Karataş

Anesthesiology and Reanimation Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sevim ŞENOL KARATAŞ,, MD

Role: CONTACT

+90 532 573 6611

Facility Contacts

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Sevim Şenol Karataş, MD

Role: primary

05325736611

Sait F Öner, MD

Role: backup

+905336271358

References

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Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.

Reference Type BACKGROUND
PMID: 11227580 (View on PubMed)

Lin 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.

Reference Type BACKGROUND
PMID: 34164409 (View on PubMed)

Li 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.

Reference Type BACKGROUND
PMID: 33758567 (View on PubMed)

Other Identifiers

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FSH-ANES-SEP-SLEEP-2025

Identifier Type: -

Identifier Source: org_study_id

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