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

Completed

• Conditions: Combined Spinal-epidural Anesthesia
• Interventions: Procedure: Combined spinal epidural anesthesia

• Registration Number: NCT05053633
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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 hernia patients.

Detailed Description

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 hernia patients undergoing combined spinal epidural anesthesia procedures.

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-09-22
• Study Start: 2021-09-25
• Primary Completion: 2023-02-25
• Study Completion: 2023-05-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age between 18- 80 years
• ASA physical status I or II
• Scheduled for inguinal hernia, umbilical hernia or incisional repair 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combined spinal epidural anesthesia	Combined spinal epidural anesthesia	The assessments are conducted in conscious patients under the procedure of Combined spinal epidural anesthesia.

Primary Outcome Measures

Name	Time	Method
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	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)	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.

Secondary Outcome Measures

Name	Time	Method
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 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)	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).

Trial Locations

Locations (1)

Beijing Chao Yang Hospital; 🇨🇳 Beijing, Beijing, China