Completed

NCT Number: NCT05615441

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

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.

Completed

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Key information

Conditions

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

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analgesia Nociception Index monitor

Device

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

Standard monitoring

Device

Patients will receive remimazolam-based total intravenous general anesthesia based on hemodynamic monitoring and without nociception monitoring

Primary outcomes

Intraoperative remifentanil requirement

Time frame: Within the intraoperative period

Intraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Nov 14, 2022
Registry last updated: Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.