Sedation With Remimazolam During Spinal Anesthesia

NCT ID: NCT05305248

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2022-09-15

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.

Conditions

Sedation; Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Remimazolam group

Sedation with remimazolam during spinal anesthesia

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

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.

Dexmedetomidine group

Sedation with dexmedetomidine during spinal anesthesia

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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.

Interventions

Remimazolam

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.

Intervention Type: DRUG

Dexmedetomidine

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Do-Hyeong Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gangnam Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

3-2021-0489

Identifier Type: -

Identifier Source: org_study_id