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Sedation With Remimazolam During Spinal Anesthesia

NCT05305248 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-05-12

No results posted yet for this study

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

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2022-09-15
Completion
2022-09-15

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05305248 on ClinicalTrials.gov