Remimazolam and Emergence Delirium in Pediatrics

Not Applicable

Recruiting

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

• Registration Number: NCT07046364
• Lead Sponsor: Peking University First Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2025-01-01
• Study First Submitted: 2025-06-15
• Study First Submitted QC: 2025-06-28
• Last Update Submitted: 2025-06-28
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Emergence delirium	The subjects were evaluated at 10 minutes, 20 minutes, 30 minutes after admission to PACU or before discharge	The Cornell Assessment of Pediatric Delirium (CAPD) was used to assess delirium. It consists of a total of 8 items, with each item scored from 0 to 4. Delirium can be diagnosed when the total score is ≥ 10.

Secondary Outcome Measures

Name	Time	Method
Sleep quality within 3 days after surgery	Within 3 days after surgery	The Numeric Rating Scale (NRS) was used for sleep quality assessment of children by their parents/caregivers within 3 days after surgery. The scores of NRS ranging from a minimum of 0 to a maximum of 10. A lower score indicates poorer sleep quality.
Postoperative delirium	Delirium was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery	The Cornell Assessment of Pediatric Delirium (CAPD) scale was used to assess whether the subjects developed delirium. It consists of a total of 8 items, with each item scored from 0 to 4. Delirium can be diagnosed when the total score is ≥ 10.
Pain score	Pain intensity was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery	The FLACC behavioral rating scale was used to evaluate the pain intensity. It mainly includes five indicators: Facial Expression, Legs, Activity, Cry, and Consolability. The score is the sum of the above five indicators, ranging from a minimum of 0 to a maximum of 10. A higher score indicates more obvious discomfort and pain.
Sleep quality 7 days after surgery and 1 month after surgery	7 days after surgery and 1 month after surgery	The Tayside Children's Sleep Questionnaire (TCSQ) was adopted to assess the sleep quality 7 days after surgery and 1 month after surgery.The TCSQ consists of 10 questions, with scores ranging from a minimum of 0 to a maximum of 40. A higher score indicates poorer sleep quality.
Postoperative adverse behavior change	1st, 3rd days after surgery	Post-hospitalization behavior questionnaire (PHBQ) was used to evaluate the postoperative adverse behavior change. It consists of 26 items, with scores ranging from a minimum of -52 to a maximum of 52. A higher score indicates poorer sleep quality.

Trial Locations

Locations (2)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China