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Clinical Trials/NCT05063461
NCT05063461
Completed
Not Applicable

Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane

Beijing Chao Yang Hospital1 site in 1 country32 target enrollmentSeptember 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Anesthesia
Sponsor
Beijing Chao Yang Hospital
Enrollment
32
Locations
1
Primary Endpoint
To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Analgesia Nociception Index(ANI)which is derived from heart rate variability can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.

Detailed Description

General anesthesia with sevoflurane and remifentanil is widely used in minor surgeries. Monitoring noxious stimulation during general anesthesia is still worth further studies and reaching clinical consensus. Analgesia Nociception Index can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. Previous studies suggest that an ANI≥50 can be useful in detecting sufficient analgesia for patients who cannot self-report pain. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.

Registry
clinicaltrials.gov
Start Date
September 25, 2021
End Date
March 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
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- 65 years
  • ASA physical status I or II
  • Elective surgery in general anesthesia planned
  • Written informed consent

Exclusion Criteria

  • Use of CNS-active medication or abuse of alcohol
  • Presents of any neuromuscular or neurologic disease
  • History of cardiac arrhythmia
  • Pregnancy or using a pacemaker

Outcomes

Primary Outcomes

To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.

Time Frame: Change from Baseline ANI that 2 minutes after applied tetanic stilumation

Tetanic stimulations are applied at different effect site concentrations of remifentanil under sevoflurane anesthesia. ANI is range from 0-100. Bigger number means better analgesic level. ANI≥50 is considered to be under adequate analgesia. Tetanic stimulation is a standard tester of nociceptive stimulus. The number of ANI will fall down if the patient is feeling pain.

Secondary Outcomes

  • The heart rate predictability for tetanic noxious stimuli(Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation)
  • The ANI predictability for tetanic noxious stimuli(Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation)
  • The Bispectral Index predictability for tetanic noxious stimuli(Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation)

Study Sites (1)

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