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

NCT ID: NCT05615441

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2024-11-01

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

ANI-guided

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

Group Type: ACTIVE_COMPARATOR

Analgesia Nociception Index monitor

Intervention Type: DEVICE

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

Standard

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

Group Type: EXPERIMENTAL

Standard monitoring

Intervention Type: DEVICE

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

Interventions

Analgesia Nociception Index monitor

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

Intervention Type: DEVICE

Standard monitoring

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seokyung Shin

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Seokyung Shin

Role: CONTACT

skshin@yuhs.ac

82-2-2228-5785

Facility Contacts

Seokyung Shin

Role: primary

skshin@yuhs.ac

82-2-2228-5785

Other Identifiers

4-2022-1155

Identifier Type: -

Identifier Source: org_study_id