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

NCT05615441 | Unknown

• 1 other identifier: 4-2022-1155
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Intraoperative remifentanil requirement

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

  Within the intraoperative period

Study Arms (2)

ANI-guided

ACTIVE COMPARATOR

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

Device: Analgesia Nociception Index monitor

Standard

EXPERIMENTAL

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

Device: Standard monitoring

Interventions

Analgesia Nociception Index monitor DEVICE

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

ANI-guided

Standard monitoring DEVICE

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

Standard

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Seokyung Shin

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seokyung Shin

CONTACT

82-2-2228-5785; skshin@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: November 2, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)