Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
248 participants
INTERVENTIONAL
2025-01-01
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Remimazolam group
A loading dose of remimazolam 0.3 mg/Kg was given at anesthesia induction and followed with 1 mg/Kg/h until 10 minutes before the end of surgery. Sevoflurane was used to maintain BIS between 40-60.
Remimazolam
After anesthesia induction, a loading investigational drug at a rate of \[3.6\*kg\] ml/h (lasting for 5 minutes, equivalent to 0.3 mg/kg of remimazolam), and then adjust the infusion rate to \[1\*kg\] ml/h (equivalent to 1 mg/kg of remimazolam). The infusion is expected to stop 10 minutes before the end of the surgery.
Normal saline group
An identical volume of normal saline was given as placebo. Patients received sevoflurane to maintain anesthesia depth (BIS) 40-60
Normal Saline
After anesthesia induction, a loading investigational drug at a rate of \[3.6\*kg\] ml/h (lasting for 5 minutes, equivalent to 0.3 mg/kg of normal saline), and then adjust the infusion rate to \[1\*kg\] ml/h (equivalent to 1 mg/kg of normal saline). The infusion is expected to stop 10 minutes before the end of the surgery.
Interventions
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Remimazolam
After anesthesia induction, a loading investigational drug at a rate of \[3.6\*kg\] ml/h (lasting for 5 minutes, equivalent to 0.3 mg/kg of remimazolam), and then adjust the infusion rate to \[1\*kg\] ml/h (equivalent to 1 mg/kg of remimazolam). The infusion is expected to stop 10 minutes before the end of the surgery.
Normal Saline
After anesthesia induction, a loading investigational drug at a rate of \[3.6\*kg\] ml/h (lasting for 5 minutes, equivalent to 0.3 mg/kg of normal saline), and then adjust the infusion rate to \[1\*kg\] ml/h (equivalent to 1 mg/kg of normal saline). The infusion is expected to stop 10 minutes before the end of the surgery.
Eligibility Criteria
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Inclusion Criteria
* Planned to receive elective neurosurgery under general anesthesia
* Expected duration of surgery \> 1 hour
Exclusion Criteria
* Use of other sedatives within 12 hours before surgery such as benzodiazepines, propofol, chloral hydrate, etc.,
* ASA classification IV or above
* Unable to complete emergence delirium assessment, such as language, hearing or vision impairment.
1 Year
6 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Mu Dong Liang
Professor
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-407-002
Identifier Type: -
Identifier Source: org_study_id
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