NCT07416773

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

February 11, 2026

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Postoperative day 7 and postoperative day 15

Study Arms (2)

Total Intravenous Anesthesia (TIVA)

Inhalational Anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fethi Sekin City Hospital

Elâzığ, Elaziğ, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

November 15, 2025

Primary Completion

March 10, 2026

Study Completion

March 15, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations