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

Sponsor
Beijing Chao Yang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05063461
Collaborator
(none)
45
1
12.2
3.7

Study Details

Study Description

Brief Summary

Analgesia Nociception Index(ANI)which is derived by heart rate variability can be used to detect noxious stimulation during propofol while changing remifentanil concentrations.The aim of this study is to evaluate whether ANI can detect noxious stimulation under sevoflurane with different concentrations of remifentanil.

Condition or Disease Intervention/Treatment Phase
  • Device: tetanic stimulation
  • Procedure: skin incision

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.The aim of this study is to evaluate whether ANI can detect noxious stimulation under sevoflurane with different concentrations of remifentanil.

Study Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane
Actual Study Start Date :
Sep 25, 2021
Actual Primary Completion Date :
Oct 8, 2021
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
sevoflurane with remifentanil

patients receive standardized sevoflurane with different concentrations of remifentanil

Device: tetanic stimulation
Using a standard muscle relaxometer to generate tetanic stimulation

Procedure: skin incision
To assess the predictive performance of ANI, when ANI indicated sufficient concentration of remifentanil induced by tetanic stimulation, applied skin incision under this concentration to verify the prediction of ANI performance.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of ANI at different analgesic levels [Change from Baseline ANI that 2 minutes after applied tetanic stilumation]

    Tetanic stimulations are applied at different effect-site concentrations of remifentanil under sevoflurane. ANI is range from 0-100. Bigger number means better analgesic level. 50-70 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 Outcome Measures

  1. Evaluation of Systolic Blood Pressure at different analgesic levels [Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation]

    Systolic Blood Pressure will go up if patient is feeling pain.

  2. Evaluation of Heart Rate at different analgesic levels [Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation]

    Heart Rate will go up if patient is feeling pain.

  3. Evaluation of Bispectral Index at different analgesic levels [Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation]

    Bispectral Index will go up if patient is feeling pain.

  4. To verify the prediction of ANI performance [Change from Baseline Bispectral Index that 2 minutes after applied skin incision]

    when ANI indicated sufficient concentration of remifentanil induced by tetanic stilumation, applied skin incision under this concentration, ANI and hemodynamic variations will not imply that patient is feeling pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 pacemaker

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chao Yang Hospital Beijing Beijing China 100020

Sponsors and Collaborators

  • Beijing Chao Yang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changwei Wei, Deputy chief physician, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT05063461
Other Study ID Numbers:
  • 00375930
First Posted:
Oct 1, 2021
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 16, 2022