Heart Rate Variability and Anxiety as Predictors of Emergence Agitation After Septorhinoplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorKonya City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients (18-65 years, ASA I-II) undergoing elective septorhinoplasty under routine general anesthesia at a single center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Emergence Agitation
Group B: No Emergence Agitation
Trial outcomes
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.
Time frame
First 30 minutes after arrival to the PACUSecondary outcomes
1
Incidence of Laryngospasm
Occurrence of clinically diagnosed laryngospasm during emergence from anesthesia or early recovery.
Time frame
From extubation until discharge from the PACU2
Postoperative Nausea and Vomiting (PONV)
Incidence and severity of postoperative nausea and vomiting assessed using a 4-point scale.
Time frame
Within 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov