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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07389135
Enrollment
100
Registered
2026-02-05
Start date
2026-02-01
Completion date
2026-09-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation, Heart Rate Variability (HRV), Septorhinoplasty

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.

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.

Interventions

None listed

Sponsors

Konya City Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Emergence AgitationFirst 30 minutes after arrival to the PACUEmergence 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

MeasureTime frameDescription
Incidence of LaryngospasmFrom extubation until discharge from the PACUOccurrence of clinically diagnosed laryngospasm during emergence from anesthesia or early recovery.
Postoperative Nausea and Vomiting (PONV)Within 24 hours postoperativelyIncidence and severity of postoperative nausea and vomiting assessed using a 4-point scale.

Countries

Turkey (Türkiye)

Contacts

CONTACTMahmut TUTAR, MD
masatu42@gmail.com+905552723704

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026