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Search / Trial NCT07046364

Remimazolam and Emergence Delirium in Pediatrics

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Jun 28, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Emergence Delirium Remimazolam Pediatric Neurosurgery Sevoflurane Anesthesia

ClinConnect Summary

This clinical trial is looking at whether adding a medicine called remimazolam to the usual anesthesia (sevoflurane) can help reduce a problem called emergence delirium in children having brain surgery. Emergence delirium is when kids become confused, restless, or agitated as they wake up from anesthesia, which can be upsetting and sometimes unsafe. Previous research suggested that remimazolam might lower the chances of this happening, so this study wants to see if giving remimazolam along with regular anesthesia makes a difference.

Children between 1 and 6 years old who are scheduled for planned brain surgery lasting more than an hour may be able to join the study. To participate, kids should not have allergies to certain sedative medicines, should not have taken other sedatives recently, and need to be able to complete checks for emergence delirium (meaning no major hearing, vision, or language difficulties). If a child joins, they will receive anesthesia with or without remimazolam during surgery, and doctors will carefully watch how they wake up to see if the medicine helps reduce confusion or agitation. This study is currently recruiting participants, and the goal is to find safer ways to help children recover more comfortably after brain surgery.

Gender

ALL

Eligibility criteria

  • 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.

About Peking University First Hospital

Peking University First Hospital is a leading medical institution in China, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its extensive expertise in various medical fields to conduct rigorous studies aimed at improving patient outcomes and contributing to global medical knowledge. With a multidisciplinary team of skilled researchers and clinicians, Peking University First Hospital is dedicated to the ethical conduct of clinical research, ensuring the highest standards of safety and efficacy in its trials. The institution plays a vital role in translating scientific discoveries into effective treatments, thereby enhancing the quality of care for patients both locally and worldwide.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported