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RecruitingNCT07389135

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

The Role of Heart Rate Variability and Anxiety in Predicting Emergence Agitation in Patients Undergoing Septorhinoplasty : A Prospective Observational Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Konya City Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed description

Emergence agitation is a clinically relevant phenomenon during early recovery from general anesthesia and may be influenced by individual autonomic function and psychological factors. Heart rate variability (HRV) reflects autonomic nervous system activity, while preoperative anxiety has been associated with adverse recovery profiles in some surgical settings. This study will investigate the relationship between preoperative HRV, anxiety, and emergence agitation in adults undergoing elective septorhinoplasty. This is a single-center, prospective observational study. Eligible patients will be adults scheduled for elective septorhinoplasty under routine general anesthesia care. Before surgery, participants will complete a preoperative anxiety assessment using a visual analog scale (VAS) and the State-Trait Anxiety Inventory (STAI-1). Resting HRV will be recorded preoperatively while the patient is at rest using a chest-strap heart rate monitor; time- and frequency-domain parameters (e.g., SDNN, RMSSD, LF/HF) will be calculated. Postoperatively, emergence agitation will be evaluated in the PACU using the Richmond Agitation-Sedation Scale (RASS) at regular intervals during the first 30 minutes of recovery; emergence agitation will be defined as a RASS score ≥ +1. Additional peri-recovery observations will include postoperative nausea and vomiting (PONV) assessed over the first 24 hours and the occurrence of laryngospasm based on clinical criteria. The primary objective is to determine whether preoperative HRV metrics and anxiety measures are associated with emergence agitation and to explore their predictive value.

Conditions

Timeline

Start date
2026-02-01
Primary completion
2026-07-01
Completion
2026-08-01
First posted
2026-02-05
Last updated
2026-03-31

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07389135. Inclusion in this directory is not an endorsement.