Relationship Between ANI, Anxiety, and Pain in Conscious Patients Undergoing CSEA

Study Overview
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Brief Summary
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Analgesia Nociception Index can be used to detect noxious stimulation during general anesthesia.The aim of this study is to observe ANI under combined spinal epidural anesthesia procedures in conscious patients.

Detailed Description
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Analgesia Nociception Index which is derived by heart rate variability, can be used to detect noxious stimulation during general anesthesia. However, the impact of anxiety on ANI evaluation and the correlation between ANI, pain, and anxiety in awake patients remains unclear. This study aimed to investigate the correlation between ANI, pain, and anxiety in conscious patients undergoing combined spinal epidural anesthesia procedures.

Official Title
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Relationship Between Analgesia Nociception Index, Anxiety, and Pain in Conscious Patients Undergoing Combined Spinal Epidural Anesthesia

Conditions
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Combined Spinal-epidural Anesthesia

Intervention / Treatment
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* Procedure: Combined spinal epidural anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18- 65 years ASA physical status I or II Scheduled for elective knee or ankle ligament reconstruction surgeries under CSEA Written informed consent Exclusion Criteria: Use of CNS-active medication or abuse of alcohol History of cardiac arrhythmia Contraindications of combined spinal epidural anesthesia Previous exposure to CSEA or surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Combined spinal epidural anesthesia<br>The assessments are conducted in conscious patients under the procedure of Combined spinal epidural anesthesia. | Procedure: Combined spinal epidural anesthesia<br>* The Anxiety (Visual Analogue Scale for Anxiety), pain (Visual Analogue Scale), and the Analgesia Nociception Index (ANI) assessments are conducted at four specific time points: lateral position, local anesthesia, epidural needle puncture and 2 minutes after puncture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between ANI and pain (measured with Visual Analog Scale,VAS), ANI and anxiety (measured with Visual Analog Scale-Anxiety,VAS-A) changes in conscious patients during anesthesia procedures | ANI is derived from hear rate variability, ranging from 0-100, bigger number means better analgesic level. Patients undergoing CSEA may experience mid-level anxiety while remaining conscious. The anxiety (VAS-A), pain (VAS), and ANI assessments were conducted at four specific time points. | The changes of ANI, VAS, and VAS-A, from baseline at different Time-points to 2min after anesthesia procedures, (Timepoints: T1=after lateral position, T2=local anesthesia, T3=epidural needle puncture, and T4=2 minutes after puncture) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between pain (measured with Visual Analog Scale,VAS) and anxiety (measured with Visual Analog Scale-Anxiety,VAS-A) changes in conscious patients during anesthesia procedures | The anxiety (VAS-A) and pain (VAS) were conducted at three specific time points, since there is no stimulus at lateral position (Timepoints: T2=local anesthesia, T3=epidural needle puncture, and T4=2 minutes after puncture). | The changes of VAS, and VAS-A, from baseline at different Time-points to 2min after anesthesia procedures, (Timepoints: T2=local anesthesia, T3=epidural needle puncture, and T4=2 minutes after puncture) |