Status:

COMPLETED

Sedation With Remimazolam During Spinal Anesthesia

Lead Sponsor:

Gangnam Severance Hospital

Conditions:

Sedation

Spinal Anesthesia

Eligibility:

All Genders

19+ years

Phase:

NA

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 clearan...

Eligibility Criteria

Inclusion

  • 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

Exclusion

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

Key Trial Info

Start Date :

April 19 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 15 2022

Estimated Enrollment :

62 Patients enrolled

Trial Details

Trial ID

NCT05305248

Start Date

April 19 2022

End Date

September 15 2022

Last Update

May 12 2023

Active Locations (1)

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1

Gangnam Severance Hospital

Seoul, South Korea