The Effect of Remimazolam on Emergence Delirium in Pediatrics Undergoing Neurosurgery With Sevoflurane Anesthesia
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Emergence delirium is a common complication in pediatrics undergoing neurosurgery. Previous study showed that a single bolus of remimazolam was associated with lower incidence of postoperative agitation. Present study was designed to investigate if remimazolam supplemented to sevoflurane anesthesia could decrease the risk of emergence delirium in pediatrics undergoing neurosurgery.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 6
Healthy Volunteers: f
View:
• Aged 1 to 6 years old
• Planned to receive elective neurosurgery under general anesthesia
• Expected duration of surgery \> 1 hour
Locations
Other Locations
China
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Dong-liang Mu
mudongliang@bjmu.edu.cn
+86 010 83575138
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 248
Treatments
Experimental: 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.
Placebo_comparator: Normal saline group
An identical volume of normal saline was given as placebo. Patients received sevoflurane to maintain anesthesia depth (BIS) 40-60
Related Therapeutic Areas
Sponsors
Leads: Peking University First Hospital