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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-25

Study Completion Date

2023-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Analgesia Nociception Index (ANI) During Propofol/Remifentanil and Sevoflurane/Remifentanil Anesthesia

NCT01522508

General Anaesthesia

UNKNOWN

Evaluation of NoL Index and ANI After Nociceptive Stimulation at Different Infusion Rates of Remifentanil Infusion

NCT02602379

Pain

COMPLETED

Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam

NCT06432894

Pain Measurement

RECRUITING

Correlation Between qNOX and Analgesia Nociception Index (ANI) Values During General Anesthesia

NCT06351072

Analgesia

COMPLETED

Composite Variability Index Versus Bispectral Index (BIS)

NCT01053611

Sedation During

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

General Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Tetanic stimulation

Intervention Type DEVICE

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

Skin incision

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tetanic stimulation

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

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No