Comparison of Postoperative QoR-15 Scores Between Desflurane and Remimazolam in Lumbar Fusion Surgery

Study Overview
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Brief Summary
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The purpose of the study is to compare the quality of recovery (QoR)-15 scores according to the use of maintenance anesthetics in the lumbar fusion surgery. Total intravenous anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and malignant hyperthermia. However, it is still not enough to explain which is better between TIVA or inhalation anesthesia. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA with remimazolam. The hypothesis of our study is that total intravenous anesthesia based on remimazolam will demonstrate better quality of recovery compared with the anesthesia based on inhalation using desflurane.

Official Title
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Comparison of Quality of Recovery (QoR)-15 Scores According to the Anesthetics (Desflurane vs. Remimazolam) in the Patients With Lumbar Fusion Surgery: a Prospective Double-blind Randomized Controlled Trial

Conditions
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Lumbar Fusion Surgery

Intervention / Treatment
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* Drug: Desﬂurane
* Drug: Remimazolam


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, BMI <30 undergoing lumbar fusion surgery under general anesthesia 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: Desflurane group<br>General anesthesia with volatile agent of desflurane | Drug: Desﬂurane<br>* General anesthesia for patients will be inducted and maintained with desflurane inhalation and remifentanil infusion. Remimazolam group will be started with remiamazolam at 6 mg/kg/h and TCI Minto model of remifentanil for the time of anesthesia induction, and maintained at 0.5<br>|
| Active Comparator: Remimazolam group<br>Remimazolam group will be started with remiamazolam at 6 mg/kg/h and TCI Minto model of remifentanil for the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h. | Drug: Remimazolam<br>* General anesthesia for patients will be inducted and maintained with desflurane inhalation and remifentanil infusion. Remimazolam group will be started with remiamazolam at 6 mg/kg/h and TCI Minto model of remifentanil for the time of anesthesia induction, and maintained at 0.5<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 | The difference of scores in the Quality of Recovery (QoR)-15 survey between desflurane group and remimazolam group. 0 (minimum), 150 (maximum): Higher scores means better. | postoperative day 1 |