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

Not Applicable

Completed

• Conditions: General Anesthesia
• Interventions: Device: Tetanic stimulation; Procedure: Skin incision

• Registration Number: NCT05063461
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-21
• Study Start: 2021-09-25
• Study First Posted: 2021-10-01
• Primary Completion: 2023-02-28
• Status Verified: 2023-03
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-03-19
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sevoflurane with different site effect concentrations of remifentanil	Skin incision	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.
Sevoflurane with different site effect concentrations of remifentanil	Tetanic stimulation	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.

Primary Outcome Measures

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

Name	Time	Method
The heart rate predictability for tetanic noxious stimuli	Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation	Heart Rate will go up if patient is feeling pain.
The ANI predictability for tetanic noxious stimuli	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.
The Bispectral Index predictability for tetanic noxious stimuli	Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation	Bispectral Index will go up if patient is feeling pain.

Trial Locations

Locations (1)

Beijing Chao Yang Hospital; 🇨🇳 Beijing, Beijing, China