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

Capital Medical University

Status: Completed

Conditions: General Anesthesia

Treatments: Procedure: Skin incision; Device: Tetanic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05063461

00375930

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Sevoflurane with different site effect concentrations of remifentanil

Experimental group

Description:

The tetanic stimulus is conducted between laryngeal mask intubation and surgical stimulation, while no other noxious stimuli are presented. The effect site concentration of remifentanil is increased step-by-step via a Target Controlled infusion device to a concentration of 2, 4, 6 ng/ml. At least 5min of the steady-state period is maintained before tetanic stimulus.

Treatment:

Procedure: Skin incision

Device: Tetanic stimulation