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

NCT05053633 | Completed

• 1 other identifier: 00375931
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Combined Spinal-epidural Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Arms (1)

Combined spinal epidural anesthesia

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

Procedure: Combined spinal epidural anesthesia

Interventions

Combined spinal epidural anesthesia PROCEDURE

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.

Combined spinal epidural anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with ASA status I or II, aged between 18 and 80 years old, scheduled for inguinal hernia, umbilical hernia or incisional repair under CSEA were included in the study. Participants with chronic pain, cardiovascular dysfunction, arrhythmia, dysautonomia, pacemaker usage, medication affecting the autonomic nervous system, contraindications to CSEA, or previous exposure to CSEA or surgery were excluded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 22, 2021
• Study Start: September 25, 2021
• Primary Completion: February 25, 2023
• Study Completion: May 31, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

CN (1)