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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 20, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 2 months later Jul 1, 2026 → Sep 1, 2026
See other at-risk trials from Konya City Hospital

Record History

  1. Primary completion pushed from Jul 1, 2026 to Sep 1, 2026
    • Study completion pushed from Aug 1, 2026 to Sep 1, 2026
    v3
  2. Recruitment opened
    • Primary completion pushed from May 1, 2026 to Jul 1, 2026
    • Study completion pushed from Jun 1, 2026 to Aug 1, 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07389135
Lead Sponsor Konya City Hospital
Conditions
(from sponsor)		 Emergence Agitation, Heart Rate Variability (HRV), Septorhinoplasty
Related terms Emergence Delirium
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov