NCT05688345

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Remimazolam
• Propofol
• Dexmedetomidine
• Orthopedic Procedures
• Sedatives
• Brachial Plexus Block

Interventions

Type	Name	Description
DRUG	Remimazolam	The patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr.
DRUG	Propofol	Patients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion.
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.

Timeline

• Start date: 2023-02-23
• Primary completion: 2023-08-12
• Completion: 2023-08-13
• First posted: 2023-01-18
• Last updated: 2024-01-31

Locations

1 site across 1 country: South Korea