Using heart rate variability and anxiety to predict emergence agitation after septorhinoplasty
Official title: The Role of Heart Rate Variability and Anxiety in Predicting Emergence Agitation in Patients Undergoing Septorhinoplasty : A Prospective Observational Study
Run by Konya City Hospital · NCT07389135 · Data updated 2026-11-12
This study will see if preoperative heart rate variability and anxiety levels can predict emergence agitation in adults having elective septorhinoplasty under general anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Konya City Hospital Academic / other |
| Locations | 1 site (Konya, Karatay) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07389135 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 years old with ASA physical status I–II scheduled for elective septorhinoplasty who can provide informed consent and complete anxiety questionnaires.
✕Probably not a fit
Patients with known arrhythmias or autonomic dysfunction, those using medications that affect HRV, people with diagnosed anxiety disorders or on preoperative anxiolytics, pregnant or breastfeeding individuals, or those undergoing emergency surgery are unlikely to benefit from the predictive approach tested here.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center prospective observational study will enroll about 100 adults undergoing elective septorhinoplasty under general anesthesia. Preoperative resting HRV will be recorded with a chest-strap monitor and anxiety measured with a visual analog scale (VAS) and the STAI-1. Emergence agitation will be monitored in the PACU using the Richmond Agitation‑Sedation Scale (RASS) during the first 30 minutes, with RASS ≥ +1 defined as agitation. Secondary outcomes include early postoperative nausea and vomiting (PONV) and laryngospasm, and time- and frequency-domain HRV metrics (SDNN, RMSSD, LF/HF) will be analyzed for predictive associations.
Why it matters
Potential benefit: If successful, clinicians could identify patients at higher risk for emergence agitation and tailor perioperative care or monitoring to reduce recovery complications.
How similar studies have gone: Some prior studies have linked HRV and preoperative anxiety to adverse perioperative outcomes, but using these measures specifically to predict emergence agitation after septorhinoplasty is relatively novel and not yet well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 65 years * ASA physical status I-II * Scheduled for elective septorhinoplasty under general anesthesia * Able to provide informed consent and complete questionnaires Exclusion Criteria: * ASA physical status III or higher * Pregnancy or breastfeeding * Known dysrhythmia/arrhythmia or autonomic dysfunction, or use of medications that may affect autonomic function/HRV * Diagnosed anxiety disorder * Use of preoperative anxiolytic medication * Inability to understand/complete the anxiety scales/questionnaires * Emergency surgery
Where it's running
-
Konya City Hospital
Konya, Karatay, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Mahmut TUTAR, MD
- Email: masatu42@gmail.com
- Phone: +905552723704
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.