Sedation With Remimazolam During Spinal Anesthesia

Gangnam Severance Hospital62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Sedation Spinal Anesthesia

Interventions

DexmedetomidineDRUG

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: up to 30 minutes after PACU arrival

Secondary Outcomes

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

Time frame: 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

Time frame: Baseline