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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: 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. 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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing Chao Yang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Study Population

Patients scheduled for elective surgery in general anesthesia

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sevoflurane with different site effect concentrations of remifentanil; 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.

Device: Tetanic stimulation; For each participant, record the first concentration that ANI≥50 after the tetanic stimuli, as the sufficient concentration.; Procedure: Skin incision; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.	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.	Change from Baseline ANI that 2 minutes after applied tetanic stilumation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ANI predictability for tetanic noxious stimuli	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.	Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation
The heart rate predictability for tetanic noxious stimuli	Heart Rate will go up if patient is feeling pain.	Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation
The Bispectral Index predictability for tetanic noxious stimuli	Bispectral Index will go up if patient is feeling pain.	Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 00375930

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No