Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2022-10-26

Brief Summary

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

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Detailed Description

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Conditions

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Orthopedic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Remimazolam

Group Type ACTIVE_COMPARATOR

Remimazolam

Intervention Type DRUG

0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5\~1.0 mg/kg/h continuous infusion

Dexmedetomidine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Remimazolam

0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5\~1.0 mg/kg/h continuous infusion

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes