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NCT Number: NCT07389135

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

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.

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Key information

Conditions

Emergence Agitation Confusion Delirium Emergence Delirium Heart Rate Variability (HRV) Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Septorhinoplasty Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya City Hospital

Konya, Karatay, 42020, Turkey (Türkiye)

Location status: Recruiting

Location contact

MAHMUT S TUTAR

CONTACT

[email protected]

+90 5552723704

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Emergence Agitation

    Time frame: First 30 minutes after arrival to the PACU

    Emergence agitation will be assessed in the post-anesthesia care unit (PACU) using the Richmond Agitation-Sedation Scale (RASS). EA will be defined as a RASS score ≥ +1 at any assessment during the observation period.

Secondary outcomes

  1. Incidence of Laryngospasm

    Time frame: From extubation until discharge from the PACU

    Occurrence of clinically diagnosed laryngospasm during emergence from anesthesia or early recovery.

  2. Postoperative Nausea and Vomiting (PONV)

    Time frame: Within 24 hours postoperatively

    Incidence and severity of postoperative nausea and vomiting assessed using a 4-point scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmut TUTAR, MD

CONTACT

[email protected]

+905552723704

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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