Orthopedic Disorder
Conditions
Brief summary
The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.
Interventions
DRUGRemimazolam
0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5\ 1.0 mg/kg/h continuous infusion
DRUGDexmedetomidine
1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2\ 0.7 mcg/kg/h continuous infusion
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of ASA class I or II.
Exclusion criteria
* Patient refusal * Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia or coagulopathy) * Contraindications to dexmedetomidine or remimazolam administration * Allergy to dexmedetomidine or remimazolam * Baseline MOAA/S score of 4 or less * Pregnancy * Other conditions considered unsuitable by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of rescue sedative doses administered | Intraoperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline) | Intraoperative period | — |
| Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline) | Intraoperative period | — |
| Incidence of respiratory depression (respiratory rate lower than 8 per minute) | Intraoperative period | — |
| Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%) | Intraoperative period | — |
| MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert) | Intraoperative period | — |
| Intraoperative PSi (Patient State index) | Intraoperative period | — |
| Electroencephalogram data (alpha, beta, delta, theta waves) | Intraoperative period | — |
| Incidence of intraoperative bradycardia (heart rate lower than 45 bpm) | Intraoperative period | — |
| Oxygen supply at the post-anesthesia care unit | Post-anesthesia care period (immediate post-operative period) | — |
| Incidence of postoperative delirium | Immediately after the surgery, up to 5 days after surgery | — |
| Incidence of nausea/vomiting | Intraoperative period and post-anesthesia care period (immediate post-operative period) | — |
| Postoperative spinal anesthesia block level | Postoperative period, up to 12h hours after end of surgery | — |
| Duration of stay in the post-anesthsia care unit(PACU) | Immediate postoperative period | — |
| Patient satisfaction (numerical rating scale of 0~10) | Immediately after the surgery, up to 5 days after surgery | 0 Not at all satisfied, 10 very satisfied |
| Serum CRP level | Preoperative baseline and second postoperative day | — |
| Time to reach MOAA/S = 5 after end of drug infusion | Intraoperative period and post-anesthesia care period (immediate post-operative period) | — |
Countries
South Korea
Outcome results
None listed