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

Combined Spinal-epidural Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053633
• Other study ID #: 00375931
• Status: Completed
• Start date: September 25, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2023
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 patients.

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 patients undergoing combined spinal epidural anesthesia procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 31, 2023
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Combined Spinal-epidural Anesthesia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Beijing Chao Yang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)