Patients Undergoing Neurosurgery
Conditions
Brief summary
This study aims to find an excellent drug in terms of hemodynamic stability when comparing the propofol and remifentanil with the combined use of remimazolam and remifentanil. When the mean blood pressure falls by 20% or more from the baseline mean blood pressure, it is considered hypotension, and a vasopressor such as ephedrine, phenylephrine, or norpin is used to control the blood pressure to within 20% of the baseline blood pressure. If the blood pressure increases by 20% or more above the baseline mean blood pressure, nicardipine infusion or remimazolam, propofol or remifentanil should be increased to control the blood pressure.
Interventions
DRUGpropofol
during the induction, remimazolam dose was controlled according to sedline (Psi target 40)
DRUGremimazolam
During induction, remimazolam dose was controlled according to sedline (Psi target 40)
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. hypertension 2. patients undergoing neurosurgery 3. ASA I-III 4. 19-75 year-old patients
Exclusion criteria
1. emergency 2. Patients admitted on the day of surgery 3. cardiac disease 4. liver failure or liver cirrhosis 5. increased intracranial pressure(IICP) 6. mental change 7. Foreigner 8. iliteracy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of hypotension events | procedure (during induction before the surgery) | Hypotension is considered when the mean blood pressure is 20% or more below the baseline mean blood pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | procedure (during induction before the surgery) | Blood pressure will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups. |
| heart rate | procedure (during induction before the surgery) | heart rate will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups. |
| sedline psi | procedure (during induction before the surgery) | sedline psi will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups. |
Countries
South Korea
Outcome results
None listed