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

NCT ID: NCT05053633

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-25

Study Completion Date

2023-05-31

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 hernia 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 hernia patients undergoing combined spinal epidural anesthesia procedures.

Conditions

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Combined Spinal-epidural Anesthesia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Combined spinal epidural anesthesia

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

Combined spinal epidural anesthesia

Intervention Type 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.

Interventions

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Combined spinal epidural anesthesia

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Changwei Wei

Deputy chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Chao Yang Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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00375931

Identifier Type: -

Identifier Source: org_study_id

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