Anesthesia, Spinal, Orthopedic Procedures, Propofol, Remimazolam, Sedatives
Conditions
Brief summary
The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.
Interventions
DRUGRemimazolam
Patients receive remimazolam at a rate of 1 mg/kg/hr. When a patient's MOAA/S reaches 3 or less, the rate of remomazolam is maintained at a rate between 0.3 mg/kr/hr and 1.0 mg/kg/hr until the end of surgery.
DRUGPropofol
Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status 1-3 * Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam
Exclusion criteria
* Patients who refuse to participate in this study * Patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease * Patients with an allergy to propofol, fentanyl, or bupivacaine * Patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region * Patients judged to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of hypotension during surgery (1hour) | up to 1 hour after initiation of drug infusion | mean blood pressure less than 65mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of hypotension during surgery | Throughout the surgery | mean blood pressure less than 65mmHg |
| Total administered phenylephrine | Throughout the surgery | total dose of phenylephrine administered during surgery |
| Fluid volume | Throughout the surgery | Total amount of fluid infused during surgery |
| Number of hypotensive episodes in the post-anesthesia care unit after surgery | up to 1 hour after postanesthesia care unit entry | mean blood pressure less than 65mmHg |
| Complications after surgery | up to 7 days after surgery | Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting |
Countries
South Korea
Outcome results
None listed