Sedation With Remimazolam During Spinal Anesthesia

Not Applicable

Completed

• Conditions: Sedation; Spinal Anesthesia
• Interventions: Drug: Remimazolam; Drug: Dexmedetomidine

• Registration Number: NCT05305248
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-04-19
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam group	Remimazolam	Sedation with remimazolam during spinal anesthesia
Dexmedetomidine group	Dexmedetomidine	Sedation with dexmedetomidine during spinal anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of