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Completed

NCT Number: NCT05063461

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

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.

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Key information

Conditions

General Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tetanic stimulation

Device

For each participant, record the first concentration that ANI≥50 after the tetanic stimuli, as the sufficient concentration.

Skin incision

Procedure

Infuse the sufficient concentration for at least 5min of the steady-state period, then surgical stimulus is applied. The surgical stimulus is defined as the first skin incision to establish pneumoperitoneum.

Primary outcomes

  1. 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

  1. The ANI predictability for tetanic noxious stimuli

    Time frame: Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation

    ANI is range from 0-100. Bigger number means better analgesic level. ANI≥50 is considered to be under adequate analgesia. The number of ANI will fall down if the patient is feeling pain.

  2. The heart rate predictability for tetanic noxious stimuli

    Time frame: Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation

    Heart Rate will go up if patient is feeling pain.

  3. The Bispectral Index predictability for tetanic noxious stimuli

    Time frame: Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation

    Bispectral Index will go up if patient is feeling pain.

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 1, 2021
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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