Sedation, Spinal Anesthesia
Conditions
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.
Interventions
DRUGRemimazolam
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.
DRUGDexmedetomidine
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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Severe cardiovascular or respiratory disease 2. Contraindication to spinal anesthesia 3. Heart block 4. Previous hepatectomy or liver transplant 5. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal) 6. Estimated glomerular filtration rate \< 30 mL/min/1.73m2 7. Acute narrow angle glaucoma 8. Myasthesia gravis 9. Known allergy to the drugs included in the study
Exclusion criteria
1. Patients 19 years of age or older who are expected to elective orthopedic surgery under spinal anaesthesia 2. ASA PS 1-3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MOAA/S score | up to 30 minutes after PACU arrival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation induction time Sedation induction time | up to 5 minutes after initation of sedative drugs | Sedation induction time is defined as from start of drug injection to the first time of MOAA/S ≤ 3 |
| Differences in basic vital signs between the two groups | Baseline | Differences in blood pressure, heart rate, and patient sedation index at different time points during the operation and PACU stay between the two groups |
Countries
South Korea
Outcome results
None listed