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Comparison of Emergence Delirium: Remimazolam vs Sevoflurane Anesthesia

NCT06214117 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-01-19

No results posted yet for this study

Summary

Emergence delirium can lead to a range of clinical problems and is even associated with short-term behavioral changes in children. Pediatric ear, nose, and throat (ENT) surgery is one of the most common surgical types for postoperative delirium in children. Sevoflurane anesthesia is also a known cause of postoperative delirium. Therefore, this study aims to explore whether there is a difference in the incidence of postoperative delirium in children under remimazolam general anesthesia and sevoflurane anesthesia.

Conditions

  • Emergence Delirium

Interventions

DRUG

Remimazolam

Anesthesia induction:intravenous Fentanyl 2-3 μg/kg, remimazolam 0.3-0.5 mg/kg and Rocuronium 0.6mg/kg; Maintenance of anesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h), and remifentanil will administer at an initial infusion rate of 0.25 μg/kg/min (0.1-0.5 μg/kg/min).

DRUG

Sevoflurane

Anesthesia induction: Anesthesia will induce with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min, and then intravenous fentanyl (2-3 μg/kg) and rocuronium (0.6 mg/kg); Maintenance of anaesthesia: Anesthesia depth will maintain at 1-1.5 minimum alveolar concentration (MAC), and remifentanil was infuse at an initial rate of 0.25 μg/kg/min (0.1-0.5 μg/kg/min).

Sponsors & Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Huacheng Liu, Ph.D. · The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2025-02-28
Completion
2025-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06214117 on ClinicalTrials.gov