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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05615441

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery	Device: Analgesia Nociception Index monitor Device: Standard monitoring	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 2, 2022

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ANI-guided Patients receiving remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor	Device: Analgesia Nociception Index monitor Patients will receive remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor
Experimental: Standard Patients receiving remimazolam-based total intravenous general anesthesia based on hemodynamic variables and without ANI nociception monitoring	Device: Standard monitoring Patients will receive remimazolam-based total intravenous general anesthesia based on hemodynamic monitoring and without nociception monitoring

Arm

Intervention/Treatment

Active Comparator: ANI-guided

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

Device: Analgesia Nociception Index monitor

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

Experimental: Standard

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

Device: Standard monitoring

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

Outcome Measures

Primary Outcome Measures

Intraoperative remifentanil requirement [Within the intraoperative period]
Intraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Seokyung Shin, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05615441

Other Study ID Numbers:

4-2022-1155

First Posted:

Nov 14, 2022

Last Update Posted:

Nov 14, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Nov 14, 2022