The Relationship Between the Surgery-related Anxiety and HRV: Prediction for Aggressive Emergence Behavior

Closed Reduction Surgery for Nasal Bone Fracture Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282865
• Other study ID #: 4-2014-0599
• Status: Completed
• Start date: September 11, 2014
• Est. completion date: March 3, 2017

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system. Anxiousness, which tend to result from the deficient action of parasympathetic nervous system, likely to show low HRV. This study is to investigate the relationship between the surgery-related anxiety and the HRV which is known to reflect the balance of autonomic nervous system. Furthermore, this study also focuses on HRV's role as a predictor for aggressive emergence behavior, which might also be considered as partially related to imbalance of autonomic nervous system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 3, 2017
• Est. primary completion date: March 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 20-60 years old male, ASA 1-2

2. scheduled for elective closed reduction for nasal bone fracture

Exclusion Criteria:

1. Patients having hearing difficulties, Foreigner, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale < 15

2. patients with severe cardiopulmonary dysfunction

3. patients taking any neurologic medication (anti-depressant, anti-convulsant, etc)

4. patients taking any cardiovascular medication

5. patients taking medications affecting the autonomic nervous system (a-blocker, b-blocker, etc)

6. patients refusal

Related Conditions & MeSH terms

• Closed Reduction Surgery for Nasal Bone Fracture
• Fractures, Bone

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High frequency (HF) of Heart Rate Variability (HRV)	High frequency (HF) component of HRV, which represents the parasympathetic activity	from immediately after tracheal intubation to 5 min after tracheal intubation