Clinical trial

The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia

Name

20230608

Description

The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.

Trial arms

Trial start

2023-08-01

Estimated PCD

2024-06-01

Trial end

2024-06-01

Status

Not yet recruiting

Treatment

Remimazolam

0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1\~1.0 mg/kg/h continuous infusion

Arms:

Remimazolam Group

Other names:

Byfavo

Dexmedetomidine

1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2\~0.7 mcg/kg/h continuous infusion

Arms:

Dexmedetomidine group

Other names:

Precedex

Size

Primary endpoint

Incidence of intraoperative hypotension

Intraoperative period

Eligibility criteria

Inclusion Criteria: - Patient scheduled for surgery under spinal anesthesia, aged 19-79, of ASA class I, II, or III Exclusion Criteria: * Patient refusal * Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis) * Contraindications or allergy to dexmedetomidine or remimazolam administration * Emergency surgery * Pregnancy

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}

Updated at

2023-08-08

1 organization

2 products

2 indications

Organization

Pusan National University Yangsan Hospital

Product

Indication

Indication

Product