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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05615441
Enrollment
58
Registered
2022-11-14
Start date
2022-11-02
Completion date
2024-11-01
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEAnalgesia Nociception Index monitor

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

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative remifentanil requirementWithin the intraoperative periodIntraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min

Countries

South Korea

Contacts

Primary ContactSeokyung Shin
skshin@yuhs.ac82-2-2228-5785

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026