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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mahmut Tutar, MD; Phone Number: +905552723704; Email: masatu42@gmail.com

Study Locations

• Turkey (Türkiye)
  • Karatay
    • Konya, Karatay, Turkey (Türkiye), 42020
      • Recruiting
      • Konya City Hospital
      • Contact: MAHMUT S TUTAR; Phone Number: +90 5552723704; Email: masatu42@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18-65 years, ASA I-II) undergoing elective septorhinoplasty under routine general anesthesia at a single center.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Emergence Agitation; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Emergence Agitation	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.	First 30 minutes after arrival to the PACU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Laryngospasm	Occurrence of clinically diagnosed laryngospasm during emergence from anesthesia or early recovery.	From extubation until discharge from the PACU
Postoperative Nausea and Vomiting (PONV)	Incidence and severity of postoperative nausea and vomiting assessed using a 4-point scale.	Within 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: 26.06.2025/ 737-737-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to institutional policies and data privacy concerns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No