Remimazolam and Emergence Delirium in Pediatrics

Peking University

Status and phase: Enrolling; Phase 4

Conditions: Remimazolam; Sevoflurane Anesthesia; Emergence Delirium; Neurosurgery; Pediatric

Treatments: Drug: Remimazolam; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07046364

2024-407-002

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 1 to 6 years old
• Planned to receive elective neurosurgery under general anesthesia
• Expected duration of surgery > 1 hour

Exclusion criteria

• Allergy to benzodiazepine
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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248 participants in 2 patient groups, including a placebo group

Remimazolam group

Experimental group

Description:

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.

Treatment:

Drug: Remimazolam

Normal saline group

Placebo Comparator group

Description:

An identical volume of normal saline was given as placebo. Patients received sevoflurane to maintain anesthesia depth (BIS) 40-60

Treatment:

Drug: Normal Saline