Skip to main content
Clinical Trials/NCT05053633
NCT05053633
Completed
Not Applicable

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

Beijing Chao Yang Hospital1 site in 1 country24 target enrollmentSeptember 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Combined Spinal-epidural Anesthesia
Sponsor
Beijing Chao Yang Hospital
Enrollment
24
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 25, 2021
End Date
May 31, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Chao Yang Hospital
Responsible Party
Principal Investigator
Principal Investigator

Changwei Wei

Deputy chief physician

Beijing Chao Yang Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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))

Study Sites (1)

Loading locations...

Similar Trials