Sedation With Remimazolam During Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Although there have been studies on the use of remimazolam as a sedative for procedures such as endoscopy, there have been no reports of the use of remimazolam in spinal anesthesia. The purpose of this study is to compare and analyze the hemodynamics and recovery profile of patients undergoing surgery under spinal anesthesia by maintaining sedation with dexmedetomidine or remimazolam.

Official Title
-----------------
Comparison of Sedation With Intravenous Remimazolam and Dexmedetomidine During Spinal Anesthesia : Prospective Randomized Study

Conditions
-----------------
Sedation, Spinal Anesthesia

Intervention / Treatment
-----------------
* Drug: Remimazolam
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe cardiovascular or respiratory disease Contraindication to spinal anesthesia Heart block Previous hepatectomy or liver transplant Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal) Estimated glomerular filtration rate < 30 mL/min/1.73m2 Acute narrow angle glaucoma Myasthesia gravis Known allergy to the drugs included in the study Exclusion Criteria: Patients 19 years of age or older who are expected to elective orthopedic surgery under spinal anaesthesia ASA PS 1-3

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam group<br>Sedation with remimazolam during spinal anesthesia | Drug: Remimazolam<br>* After spinal anesthesia, 5 mg of remimazolam is injected by intravenous route for 1 minute to induce sedation. To maintain sedation, remimazolam is continuously infused at a rate within the range of 0.1 mg/kg/h to 1 mg/kg/h.<br>|
| Active Comparator: Dexmedetomidine group<br>Sedation with dexmedetomidine during spinal anesthesia | Drug: Dexmedetomidine<br>* After performing spinal anesthesia, dexmedetomidine is injected at a loading dose of 1 mcg/kg for 10 minutes to induce sedation. Thereafter, to maintain sedation, Dexmedetomidine is continuously infused at a rate within the range of 0.2 to 0.7 mcg/kg/h.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOAA/S score | MOAA/S score will be evaluated by an 5-point scale from iniation of sedative drugs to 30 minutes after PCAU arrival at 10 minutes intervals. | up to 30 minutes after PACU arrival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation induction time Sedation induction time | Sedation induction time is defined as from start of drug injection to the first time of MOAA/S ≤ 3 | up to 5 minutes after initation of sedative drugs | 
| Differences in basic vital signs between the two groups | Differences in blood pressure, heart rate, and patient sedation index at different time points during the operation and PACU stay between the two groups | Baseline |