Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam

Study Overview
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Brief Summary
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Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. In addition, it has no injection pain and infusion syndrome compared with propofol. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. Therefore, rhe purpose of the study is to compare poetoperative quality of recovery (QoR)-15 scores according to the use of anesthetics for total intravenous anesthesia in the cervical spine surgery with intraoperative neurophysiological monitoring.

Official Title
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Comparison of Postoperative Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics (Propofol vs. Remimazolam) During Total Intravenous Anesthesia in the Spine Surgery Patients

Conditions
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Patients Undergoing Spine Surgery

Intervention / Treatment
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* Drug: Propfol group
* Drug: Remimazolam group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who aged 20-70 years with ASA-PS 1-3, diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy intraoperative neurophysiological monitoring. Exclusion Criteria: Tolerance or hypersensitivity to benzodiazepine or propofol Dependence or addiction to psychotropic drugs or alcohol Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol group<br>Propofol based total intravenous anesthesia | Drug: Propfol group<br>* Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil under target controlled infusion (TCI) model.<br>|
| Active Comparator: Remimazolam group<br>Remimazolam based total intravenous anesthesia | Drug: Remimazolam group<br>* Remimazolam group will be started total intravenous anesthesia with remiamazolam at 6 mg/kg/h for induction, and maintained at 0.5-1.5 mg/kg/h and remifentanil under TCI model.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of QoR-15 scores between two groups (propofol vs. remimazolam) | The difference of scores in the Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores means better. | postoperative day 1 |