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

Asan Medical Center

Status and phase: Completed; Phase 4

Conditions: Remimazolam; Brachial Plexus Block; Orthopedic Procedures; Propofol; Dexmedetomidine; Sedatives

Treatments: Drug: Remimazolam; Drug: Propofol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05688345

2021-1591

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Remimazolam

Active Comparator group

Description:

Maintenance doses of remimazolam is administered for sedation

Treatment:

Drug: Remimazolam

Propofol

Active Comparator group

Description:

Propofol is administered for sedation through target-controlled infusion

Treatment:

Drug: Propofol

Dexmedetomidine

Active Comparator group

Description:

Loading and maintenance doses of dexmedetomidine are administered for sedation

Treatment:

Drug: Dexmedetomidine