Clinical trial NCT05053633: Relationship Between ANI, Anxiety, and Pain in Conscious Hernia Patients Undergoing CSEA
Official title: Relationship Between Analgesia Nociception Index, Anxiety, and Pain in Conscious Hernia Patients Undergoing Combined Spinal Epidural Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Combined Spinal-epidural Anesthesia
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: 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
timeFrame: 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:
measure: 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
timeFrame: 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)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao Yang Hospital
state: Beijing
Study officials:
References: