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

Study Overview
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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.

Official Title
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Comparison of Recovery Profiles of Propofol, Dexmedetomidine, and Remimazolam for Monitored Anesthetic Care in Patients Undergoing Upper Limb Surgery Under Brachial Plexus Block : a Randomized Controlled Trial

Conditions
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Remimazolam, Propofol, Dexmedetomidine, Orthopedic Procedures, Sedatives, Brachial Plexus Block

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Propofol
* Drug: Dexmedetomidine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remimazolam<br>Maintenance doses of remimazolam is administered for sedation | Drug: Remimazolam<br>* The patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr.<br>|
| Active Comparator: Propofol<br>Propofol is administered for sedation through target-controlled infusion | Drug: Propofol<br>* Patients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion.<br>|
| Active Comparator: Dexmedetomidine<br>Loading and maintenance doses of dexmedetomidine are administered for sedation | Drug: Dexmedetomidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery profile | Time taken for MOAA/S score to reach 5 (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0) | up to 1 hour after post-anesthesia case unit entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in post-anesthesia care unit | Length of stay from entering PACU to leaving | up to 3 hours after post-anesthesia case unit entry | 
| Intraoperative hypotension | mean blood pressure less than 60mmHg | up to 1hour from the initiation of sedative administration | 
| Occurrence of desaturation during surgery | Oxygen saturation less than 92% | From the start of sedative injection to the end of surgery or assessed up to 3 hours | 
| Duration of nerve block |  | From end of surgery until 24 hours after end of surgery | 
| patient satisfaction | 7 point Likert scale | From end of surgery until 24 hours after end of surgery | 
| Surgeon's satisfaction | 7 point Likert scale | From end of surgery until 24 hours after end of surgery |