Brachial Plexus Block, Dexmedetomidine, Orthopedic Procedures, Propofol, Remimazolam, Sedatives
Conditions
Brief 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.
Interventions
DRUGRemimazolam
The patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr.
DRUGPropofol
Patients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion.
DRUGDexmedetomidine
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.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery profile | up to 1 hour after post-anesthesia case unit entry | Time taken for MOAA/S score to reach 5 (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative hypotension | up to 1hour from the initiation of sedative administration | mean blood pressure less than 60mmHg |
| Occurrence of desaturation during surgery | From the start of sedative injection to the end of surgery or assessed up to 3 hours | Oxygen saturation less than 92% |
| Length of stay in post-anesthesia care unit | up to 3 hours after post-anesthesia case unit entry | Length of stay from entering PACU to leaving |
| patient satisfaction | From end of surgery until 24 hours after end of surgery | 7 point Likert scale |
| Surgeon's satisfaction | From end of surgery until 24 hours after end of surgery | 7 point Likert scale |
| Duration of nerve block | From end of surgery until 24 hours after end of surgery | — |
Countries
South Korea
Outcome results
None listed