Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Orthopedic Disorder

Treatments: Drug: Remimazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05447507

2205-011-1320

Details and patient eligibility

About

The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.

Enrollment: 104 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of ASA class I or II.

Exclusion criteria

• Patient refusal
• Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia or coagulopathy)
• Contraindications to dexmedetomidine or remimazolam administration
• Allergy to dexmedetomidine or remimazolam
• Baseline MOAA/S score of 4 or less
• Pregnancy
• Other conditions considered unsuitable by the investigators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

Remimazolam

Active Comparator group

Treatment:

Drug: Remimazolam

Dexmedetomidine

Active Comparator group

Treatment:

Drug: Dexmedetomidine