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

NCT07389135 | Recruiting

• 1 other identifier: 26.06.2025/ 737-737-10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergence Agitation; Heart Rate Variability (HRV); Septorhinoplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Laryngospasm

  From extubation until discharge from the PACU

• Postoperative Nausea and Vomiting (PONV)

  Within 24 hours postoperatively

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Karatay, 42020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Mahmut TUTAR, MD

CONTACT

+905552723704; masatu42@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)