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Not Yet Recruiting NCT05688345

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

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

Sex: All
Ages: 19 Years – 80 Years
Phase: PHASE4
Enrollment: 120
Sponsor: Asan Medical Center

Location: Korea, Republic of

Summary

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.

Eligibility Criteria

Inclusion Criteria:ASA PS 1-3Patients scheduled for upper extremity surgery under brachial plexus block and monitored anesthetic careExclusion Criteria:Patients who refuse to participate in this studyPatients with poorly controlled hypertension, hyperthyroidism, or moderate to severe heart diseasePatients with severe hepatic or renal diseasePatients who are chronically using antidepressants, anticonvulsants, or psychoactive drugsPatients who abuse drugs or alcoholPatients with severe sleep apneaPatients with cognitive impairment who have severe difficulties in communicationPatients with allergy to propofol, dexmedetomidine, or remimazolamPatients judged to be inappropriate for this study

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Source: ClinicalTrials.gov (NCT05688345). StuddyBuddy aggregates publicly available trial information.