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

Konya City Hospital

Status: Not yet enrolling

Conditions: Septorhinoplasty; Emergence Agitation; Heart Rate Variability (HRV)

Study type: Observational

Funder types: Other

Identifiers

NCT07389135

26.06.2025/ 737-737-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Emergence Agitation

Description:

Participants who exhibit emergence agitation during early recovery in the PACU, defined as a Richmond Agitation-Sedation Scale (RASS) score ≥ +1 within the first 30 minutes after arrival to the PACU.

No Emergence Agitation

Description:

Participants who do not exhibit emergence agitation during early recovery in the PACU, defined as RASS \< +1 throughout the first 30 minutes after arrival to the PACU.