Remimazolam, Spinal Anesthesia
Conditions
Brief summary
The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.
Detailed description
Sedation during spinal anesthesia can reduce the patient's anxiety and increase satisfaction, but sedatives such as dexmedetomidine and midazolam may cause hemodynamic instability such as hypotension and bradycardia. In previous studies , hypotension occurred in about 33% and bradycardia in about 13% during spinal anesthesia, which is related to reduced cardiac output due to sympathetic blockade and relative activation of the parasympathetic nerve. In the study comparing remimazolam and dexmedetomidine in patients with delirium after orthopedic surgery, the incidence of hypotension was lower in the remimazolam group (10.8%) than in the dexmedetomidine group (39.5%) (p=0.007) and there was no significant difference between the remimazolam group (2.7%) and the dexmedetomidine group (13.2%) in the incidence of bradycardia (p=0.200). However, the effect of remimazolam on the incidence of hypotension during spinal anesthesia has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adults patients.
Interventions
DRUGRemimazolam
0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1\ 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
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
\- Patient scheduled for surgery under spinal anesthesia, aged 19-79, of ASA class I, II, or III
Exclusion criteria
* Patient refusal * Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis) * Contraindications or allergy to dexmedetomidine or remimazolam administration * Emergency surgery * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative hypotension | Intraoperative period | mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative hypertension | Intraoperative period | mean blood pressure higher than 120 mmHg or systolic blood pressure higher than 120% of baseline |
| Incidence of respiratory depression | Intraoperative period | respiratory rate lower than 8 per minute |
| Incidence of intraoperative bradycardia | Intraoperative period | heart rate lower than 45 bpm |
| Intraoperative Ramsay sedation scale | Intraoperative period | score of 1\ 6 |
| Number of phenylephrine, ephedrine, atropine administered | Intraoperative period | number of administration |
| Incidence of hypoxia | Intraoperative period | oxygen saturation detected by pulse oxymetry less than 93% |
Contacts
Primary ContactJieun Jung, MD
Outcome results
None listed