The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5\~1.0 mg/kg/h continuous infusion
1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2\~0.7 mcg/kg/h continuous infusion
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Number of rescue sedative doses administered
Time frame: Intraoperative period
Incidence of intraoperative bradycardia (heart rate lower than 45 bpm)
Time frame: Intraoperative period
Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline)
Time frame: Intraoperative period
Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline)
Time frame: Intraoperative period
Incidence of respiratory depression (respiratory rate lower than 8 per minute)
Time frame: Intraoperative period
Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%)
Time frame: Intraoperative period
MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert)
Time frame: Intraoperative period
Intraoperative PSi (Patient State index)
Time frame: Intraoperative period
Electroencephalogram data (alpha, beta, delta, theta waves)
Time frame: Intraoperative period
Time to reach MOAA/S = 5 after end of drug infusion
Time frame: Intraoperative period and post-anesthesia care period (immediate post-operative period)
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Oxygen supply at the post-anesthesia care unit
Time frame: Post-anesthesia care period (immediate post-operative period)
Incidence of postoperative delirium
Time frame: Immediately after the surgery, up to 5 days after surgery
Incidence of nausea/vomiting
Time frame: Intraoperative period and post-anesthesia care period (immediate post-operative period)
Postoperative spinal anesthesia block level
Time frame: Postoperative period, up to 12h hours after end of surgery
Duration of stay in the post-anesthsia care unit(PACU)
Time frame: Immediate postoperative period
Patient satisfaction (numerical rating scale of 0~10)
0 Not at all satisfied, 10 very satisfied
Time frame: Immediately after the surgery, up to 5 days after surgery
Serum CRP level
Time frame: Preoperative baseline and second postoperative day