Sedation With Remimazolam During Spinal Anesthesia

NCT05305248 | Completed

• 1 other identifier: 3-2021-0489
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sedation induction time Sedation induction time

  up to 5 minutes after initation of sedative drugs

• Differences in basic vital signs between the two groups

  Baseline

Study Arms (2)

Remimazolam group

EXPERIMENTAL

Sedation with remimazolam during spinal anesthesia

Drug: Remimazolam

Dexmedetomidine group

ACTIVE COMPARATOR

Sedation with dexmedetomidine during spinal anesthesia

Drug: Dexmedetomidine

Interventions

Remimazolam 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.

Remimazolam group

Dexmedetomidine 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.

Dexmedetomidine group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients 19 years of age or older who are expected to elective orthopedic surgery under spinal anaesthesia
• ASA PS 1-3

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

remimazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 31, 2022
• Study Start: April 19, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)