Comparison of Recovery Profiles Among Propofol, Remimazolam, and Dexmedetomidine After 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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2023-08-13

Brief Summary

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A total of 120 patients (American Society of Anesthesiologist Physical Status 1-3) who signed a consent form among patients aged 19-80 years who are scheduled to undergo brachial plexus block and upper extremity surgery under monitored anesthetic care at our hospital were enrolled.

Recruited patients are divided into three groups through computer-generated randomization by using the patient identification number assigned during patient recruitment. (40 people in each group) Standard monitoring is performed when the patient arrives at the operating room. Patients receive oxygen at 5-6 L/min using a simple facial mask, and receive a brachial plexus block under ultrasound guidance. After confirming the success of brachial plexus block, administration of propofol, remimazolam, or dexmedetomidine is started according to the assigned group. Assess the patient's level of consciousness through the MOAA/S (modified observer's assessment of alertness/sedation scale) scale. The drug injection ends when the skin suture is started after the main procedure. The time from the end of injection of each drug until MOAA/S becomes 5 points is measured. After the patient is transferred to the recovery room, the Aldrete score is assessed.

The recovery profile, perioperative hemodynamic change, desaturation event, block duration, patient movement during surgery, patient satisfaction, and surgeon's satisfaction were investigated and analyzed for comparison.

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Detailed Description

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Conditions

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Remimazolam Propofol Dexmedetomidine Orthopedic Procedures Sedatives Brachial Plexus Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Remimazolam

Maintenance doses of remimazolam is administered for sedation

Group Type ACTIVE_COMPARATOR

Remimazolam

Intervention Type DRUG

The patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr.

Propofol

Propofol is administered for sedation through target-controlled infusion

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Patients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion.

Dexmedetomidine

Loading and maintenance doses of dexmedetomidine are administered for sedation

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

The patient is administered a dose of dexmedetomidine at 1 mcg/kg for 10 minutes, followed by continuous infusion at a rate of 0.2-1.0 mcg/kg/hr.

Interventions

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Remimazolam

The patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr.

Intervention Type DRUG

Propofol

Patients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion.

Intervention Type DRUG

Dexmedetomidine

The patient is administered a dose of dexmedetomidine at 1 mcg/kg for 10 minutes, followed by continuous infusion at a rate of 0.2-1.0 mcg/kg/hr.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA PS 1-3
* Patients scheduled for upper extremity surgery under brachial plexus block and monitored anesthetic care

Exclusion Criteria

* Patients who refuse to participate in this study
* Patients with poorly controlled hypertension, hyperthyroidism, or moderate to severe heart disease
* Patients with severe hepatic or renal disease
* Patients who are chronically using antidepressants, anticonvulsants, or psychoactive drugs
* Patients who abuse drugs or alcohol
* Patients with severe sleep apnea
* Patients with cognitive impairment who have severe difficulties in communication
* Patients with allergy to propofol, dexmedetomidine, or remimazolam
* Patients judged to be inappropriate for this study

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No