Neurologic Disorder
Conditions
Brief summary
This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements.
Detailed description
This study hypothesizes that the combination regimen of remimazolam and propofol as total intravenous anesthesia in neurosurgical procedures requiring neurophysiological monitoring can reduce the incidence of hypotension compared to propofol monotherapy while providing comparable levels of neurophysiological monitoring and surgical conditions. With this hypothesis, the study aims to compare the frequency, severity, and duration of hypotension, frequency of patient movement, and appropriateness of neurophysiological monitoring between the combination therapy of remimazolam and propofol and propofol monotherapy in total intravenous anesthesia.
Interventions
DRUGRemimazolam besylate + propofol MCT
remimazolam besylate 3mg/kg/hr for induction, and 0.5 mg/kg/hr for maintenance + propofol MCT 1-4 mcg/ml using target-controlled infusion
DRUGPropofol MCT
Propofol MCT 2-8 mcg/ml using target-controlled infusion
Sponsors
Chung-Ang University Gwangmyeong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 19 and above with planned neurosurgical procedures requiring neurophysiological monitoring, classified as American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3 in the United States.
Exclusion criteria
1. Patients who refuse to participate in the study. 2. Patients who are pregnant or lactating. 3. Patients with hypersensitivity to the investigational drugs or to soy, peanuts, or Dextran 40. 4. Patients with acute narrow-angle glaucoma. 5. Patients with alcohol or drug dependence. 6. Patients with hepatic impairment classified as Child-Pugh class C. 7. Patients with lactose intolerance. 8. Patients requiring emergency surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative hypotension | operation day - postoperative 1 day | mean arterial pressure \< 65mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of participants' intraoperative involuntary movement | operation day - postoperative 1 day | number of patients involuntary movement during operation (ex. no movement:0 , 3 times of movement: 3) |
| scores of neurophysiologic monitoring quality | operation day - postoperative 1 day | 0-5 scale of neurophysiologic monitoring quality, scored by neurophysiologic monitoring technologist (poor: 0, good: 5) |
| onset time of study drugs | operation day - postoperative 1 day | time from administration of study drugs(remimazolam+propofol or propofol) to Bispectral index value \< 60 |
| Amount and number of inotropic agents | operation day - postoperative 1 day | intraoperative inotropics amount (phenylephrine(mcg), ephedrine(mg), norepinephrine(mcg), dopamine(mg)) |
| Time-weighted average of intraoperative hypotension | operation day - postoperative 1 day | (depth of hypotension in millimeters of mercury below a MAP of 65mmHg × time in minutes spent below a MAP of 65mmHg)÷total duration of operation in minutes |
| recovery time of study drugs (remimazolam+propofol or propofol) | operation day - postoperative 1 day | time from discontinuation of study drugs(remimazolam+propofol or propofol) to Bispectral index value \> 60 |
| The administration number of rescue anti-emetic agents | operation day - postoperative 3 day | postoperative rescue anti-emetic agents (ramosetron, palonosetron, metoclopramide) requirements |
Contacts
Primary ContactJiwon Han, Pf.
Outcome results
None listed