Heart Rate Variability and Anxiety as Predictors of Emergence Agitation After Septorhinoplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Emergence Agitation, Heart Rate Variability (HRV), Septorhinoplasty. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Role of Heart Rate Variability and Anxiety in Predicting Emergence Agitation in Patients Undergoing Septorhinoplasty : A Prospective Observational Study
Overview
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.
Primary outcome measures
- Incidence of Emergence Agitation [Time frame: First 30 minutes after arrival to the PACU]
Secondary outcome measures (2)
- Incidence of Laryngospasm [Time frame: From extubation until discharge from the PACU]
- Postoperative Nausea and Vomiting (PONV) [Time frame: Within 24 hours postoperatively]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Konya City Hospital — Konya
Identifiers
NCT: NCT07389135 · 26.06.2025/ 737-737-10