Clinical Trial

Heart Rate Variability and Anxiety as Predictors of Emergence Agitation After Septorhinoplasty

Recruiting
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Record status
This record was last updated March 31, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This prospective observational study aims to evaluate whether preoperative heart rate variability (HRV) and anxiety are associated with, and can help predict, emergence agitation in adult patients undergoing elective septorhinoplasty under general anesthesia. Preoperative anxiety will be assessed using a visual analog scale (VAS) and the State-Trait Anxiety Inventory (STAI-1). Resting HRV will be recorded preoperatively using a chest-strap heart rate monitor and HRV metrics (e.g., SDNN, RMSSD, LF/HF) will be derived. Emergence agitation will be assessed in the post-anesthesia care unit (PACU) using the Richmond Agitation-Sedation Scale (RASS) during the early recovery period. Secondary observations will include early postoperative events such as postoperative nausea and vomiting (PONV) and laryngospasm. The study is planned to enroll approximately 100 participants.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-04-01
notable Primary completion pushed: 2026-05-01 -> 2026-07-01 2026-04-01
minor Completion pushed: 2026-06-01 -> 2026-08-01 2026-04-01
Trial Details
NCT Number NCT07389135
Lead Sponsor Konya City Hospital
Conditions Emergence Agitation, Heart Rate Variability (HRV), Septorhinoplasty
Enrollment 100 participants
Start Date 2026-02-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-31