Clinical trial

Performance Evaluation of Analgesia Nociception Index (ANI) in Patients Under General Anaesthesia With Remimazolam: a Prospective Observational Study

Name

Ilsan_Cha_2023-04-003-005

Description

The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.

Trial arms

Trial start

2024-04-23

Estimated PCD

2025-06-11

Trial end

2025-06-11

Status

Recruiting

Treatment

Analgesia Nociception Index, remimazolam

The purpose of this study is to determine the validity of ANI in patients undergoing surgery with remifentanil and remimazolam. During this study, remimazolam infusion rate is determined by the pharmacopoeia. Remifentanil infusion rate is determined based on the patient's vital signs, systemic status and pain levels. And remifentanil is administrated via targeted infusion control using the Minto model. ANI scores, vital signs, remifentanil infusion rate are collected at predetermined time points according to the protocol from the start to the end of the surgery.

Arms:

observation

Size

Primary endpoint

ANI values

During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)

Eligibility criteria

Inclusion Criteria: Patients * aged 20-79 years under general anaesthesia with remimazolam * scheduled to undergo robotic surgery * in American Society of Anesthesiologists physical class 1, 2 or 3 * voluntarily agree in writing to participate in this clinical study Exclusion Criteria: * Conditions affecting the autonomic nervous system * other conditions or disease that may cause acute or chronic pain * the NRS before induction of anesthesia is 1 or over * When taking medications that may affect the autonomic nervous system * In other cases where the investigator deems the subject unsuitable for this trial

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '20 Months', 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-05-30

1 organization

Organization

Catholic Kwandong University