Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain

Yonsei University

Status: Enrolling

Conditions: Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery

Treatments: Device: Standard monitoring; Device: Analgesia Nociception Index monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05615441

4-2022-1155

Details and patient eligibility

About

This study aims to investigate whether the use of nociception monitoring during general anesthesia with remimazolam-based total intravenous anesthesia has an effect on intraoperative opioid requirements and postoperative pain. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.

Enrollment: 58 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adult patients between 19 and 64 years of age, ASA class I~III, scheduled for arthroscopic knee surgeryunder general anesthesia.

Exclusion criteria

Patient refusal, patients unable to read consent form, active URI or uncontrolled asthma, pneumonia, history of allergies to benzodiazepines, decreased liver or kidney function, heart failure of ejection fraction<55%, pregnant or breastfeeding patients, history of substance abuse/addiction

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

ANI-guided

Active Comparator group

Description:

Patients receiving remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor

Treatment:

Device: Analgesia Nociception Index monitor

Standard

Experimental group

Description:

Patients receiving remimazolam-based total intravenous general anesthesia based on hemodynamic variables and without ANI nociception monitoring

Treatment:

Device: Standard monitoring