Actively Recruiting
The Role of Heart Rate Variability and Anxiety in Predicting Emergence Agitation in Patients Undergoing Septorhinoplasty A Prospective Observational Study
Led by Konya City Hospital · Updated on 2026-03-31
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore whether preoperative heart rate variability (HRV) and anxiety levels are linked to and can help predict emergence agitation in adults undergoing elective septorhinoplasty with general anesthesia. Emergence agitation is a notable condition during early recovery from anesthesia, possibly influenced by autonomic nervous system activity and psychological factors. The study is being conducted at a single center and plans to enroll about 100 adult patients. Participants will undergo routine general anesthesia for their septorhinoplasty. Before surgery, their anxiety will be measured 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 to calculate various HRV parameters such as SDNN, RMSSD, and LF/HF. After surgery, emergence agitation will be assessed in the post-anesthesia care unit (PACU) using the Richmond Agitation-Sedation Scale (RASS) during the first 30 minutes of recovery. Additional observations will include monitoring for postoperative nausea and vomiting (PONV) within 24 hours and laryngospasm from extubation until discharge from the PACU. Throughout the study, participants will complete anxiety questionnaires before surgery and wear the heart rate monitor to record HRV. Postoperative agitation will be regularly assessed using the RASS scale in the PACU. Researchers will track other recovery events like nausea, vomiting, and laryngospasm. The primary outcome is the incidence of emergence agitation within 30 minutes after arrival to the PACU. The study will provide insights on whether HRV and anxiety can predict early recovery agitation, with outcomes monitored until discharge from the PACU and 24 hours postoperatively.
CONDITIONS
Brief Title
Heart Rate Variability and Anxiety as Predictors of Emergence Agitation After Septorhinoplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day before surgery
Participants complete preoperative anxiety assessments and have heart rate variability recorded before surgery.
1 visit (in-person)
Duration - Up to 24 hours postoperatively
Participants are observed during the first 30 minutes after arrival to the post-anesthesia care unit (PACU) for emergence agitation and are monitored for laryngospasm until discharge from the PACU. Postoperative nausea and vomiting are assessed within 24 hours after surgery.
Continuous monitoring in PACU plus assessments within 24 hours
Trial Site Locations
Total: 1 location
1
Konya City Hospital
Konya, Karatay, Turkey (Türkiye), 42020
Actively Recruiting
Research Team
M
Mahmut TUTAR, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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