N/A N=109 Randomized Single-blind Prevention

Post Extubation Delirium and End-tidal Sevoflurane Concentration

Delirium on Emergence

Bottom Line

View on ClinicalTrials.gov: NCT02489734 ↗

Enrolled (actual)

109

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Number of Participants With Emergence Delirium (ED) — 5; 23 Participants — p=0.003

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: sevoflurane (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Children's Hospital of Fudan University
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Emergence Delirium (ED)	5; 23	0.003 sig

Summary

The purpose of this study is to determine whether the incidence of emergence delirium will be reduced when end-tidal concentration of sevoflurane decreases.

Eligibility Criteria

Inclusion Criteria

Age 2-7 years
ASA I - II
Estimated surgery time < 2 hours
Sevoflurane induction and maintenance along with caudal block or Axillary Block

Exclusion Criteria

Craniofacial anomalies
Difficult exposure of the vocal cordS
Obesity
Asthma
Invalid caudal block or axillary block

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Data sourced from ClinicalTrials.gov (NCT02489734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.