A Phase 4 interventional study of Remimazolam and Dexmedetomidine in Orthopedic Disorder, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's enrollment of 104 is above the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Remimazolam
Drug: Dexmedetomidine
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
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)
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital