Comparison of Postoperative QoR-15 Scores Between Sevoflurane and Remimazolam

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 cervical spine 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 the investigators study is that, in patients with cervical spine surgery, total intravenous anesthesia based on remimazolam can improve the the quality of recovery compared to inhalation anesthesia based on sevoflurane.

Official Title
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Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During General Anesthesia in the Cervical Spine Surgery Patients: Sevoflurane vs. Remimazolam

Conditions
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Anterior Cervical Discectomy and Fusion (ACDF) Surgery

Intervention / Treatment
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* Drug: Sevoflurane based inhalation anesthesia
* Drug: Remimazolam based total intravenous anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who aged 20-70 years ASA-PS: 1-3 BMI < 30 Anterior cervical discectomy and fusion surgery Exclusion Criteria: Tolerance or hypersensitivity to benzodiazepine 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: Arm 1) Sevoflurane group<br>Sevoflurane based inhalation anesthesia | Drug: Sevoflurane based inhalation anesthesia<br>* Sevoflurane group will be inducted with bolus of propofol 1% and maintained with sevofulrane as inhalation and TCI Minto model of remifentanil for general anesthesia.<br>|
| Active Comparator: Arm 2) Remimazolam group<br>Remimazolam based total intravenous anesthesia | Drug: Remimazolam based total intravenous anesthesia<br>* Remimazolam group will be inducted with remiamazolam at 6 mg/kg/h and maintained with remimazolam at 0.5-1.5 mg/kg/h and TCI Minto model of remifentanil for general anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between two groups (sevoflurane vs. remimazolam) in QoR-15 scores | The difference of scores in the Quality of Recovery (QoR)-15 survey on POD 1 Total 0-150, 0 (minimum), 150 (maximum), Higher scores means better. | postoperative day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical surgery, Quality of Recovery, Remimazolam, sevoflurane