A Phase 4 interventional study of Remimazolam besylate + propofol MCT and Propofol MCT in Neurologic Disorder, sponsored by Chung-Ang University Gwangmyeong Hospital. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Chung-Ang University Gwangmyeong Hospital · Phase 4, Interventional, and Treatment
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.
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.
974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.
This study's planned enrollment of 56 is above the median of 48 across 623 interventional studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →Chung-Ang University Gwangmyeong Hospital is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Combination regimen (remimazolam plus propofol)
Drug: Remimazolam besylate + propofol MCT
Propofol monotherapy
Drug: 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
Propofol MCT 2-8 mcg/ml using target-controlled infusion
Incidence of intraoperative hypotension
mean arterial pressure \< 65mmHg
Time frame: operation day - postoperative 1 day
Amount and number of inotropic agents
intraoperative inotropics amount (phenylephrine(mcg), ephedrine(mg), norepinephrine(mcg), dopamine(mg))
Time frame: operation day - postoperative 1 day
Incidence of participants' intraoperative involuntary movement
number of patients involuntary movement during operation (ex. no movement:0 , 3 times of movement: 3)
Time frame: operation day - postoperative 1 day
scores of neurophysiologic monitoring quality
0-5 scale of neurophysiologic monitoring quality, scored by neurophysiologic monitoring technologist (poor: 0, good: 5)
Time frame: operation day - postoperative 1 day
onset time of study drugs
time from administration of study drugs(remimazolam+propofol or propofol) to Bispectral index value \< 60
Time frame: operation day - postoperative 1 day
The administration number of rescue anti-emetic agents
postoperative rescue anti-emetic agents (ramosetron, palonosetron, metoclopramide) requirements
Time frame: operation day - postoperative 3 day
Time-weighted average of intraoperative hypotension
(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
Time frame: operation day - postoperative 1 day
recovery time of study drugs (remimazolam+propofol or propofol)
time from discontinuation of study drugs(remimazolam+propofol or propofol) to Bispectral index value \> 60
Time frame: operation day - postoperative 1 day
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chung-Ang University Gwangmyeong Hospital