A Study on the Effects of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery
Information source: Korea University Anam Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Child; Anesthesia Morbidity; Delirium on Emergence
Intervention: Midazolam 0.03mg/kg (Drug); Midazolam 0.05mg/kg (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Korea University Anam Hospital Official(s) and/or principal investigator(s):
Eun Jung Cho, Resident, Principal Investigator, Affiliation: Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
S.Z. Yoon, Professor, Study Director, Affiliation: Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
Summary
Sevoflurane with its rapid induction and emergence, hemodynamic stability, and nonirritating
airway properties, has acquired widespread acceptance in children. However, sevoflurane has
been reported to be associated with emergence agitation in children, with a reported
incidence of up to 80%.
The purpose of this study is to verify that the prophylactic use of midazolam, which is a
GABA A receptor inhibitor, given five minutes before the end of strabismus surgery reduces
the incidence of emergence agitation after sevoflurane anesthesia in children.
Simultaneously, this study aims to find out the proper dose of midazolam with minimum
disturbance to patient's emergence time.
Clinical Details
Official title: Comparative Study on the Effects of Capacities of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery : a Randomized Double- Blinded Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Time of emergence
Secondary outcome: Incidence of emergency agitation
Detailed description:
Sevoflurane is associated with a high incidence of emergence agitation in children. The
etiology of emergence agitation is unclear. Some studies proposed that emergence agitation
was related to a variable rate of neurologic recovery rate in different brain areas and
immaturity of neurons. Inhalation anesthetics have been known to exert transient paradoxical
excitatory effects in both animals and human patients, especially in children. The
gamma(γ)-aminobutyric acid (GABA)A receptor is the target depressant effect site of most
anesthetic drugs including sevoflurane. Midazolam acts on the benzodiazepine binding site of
GABAA receptors and results in inhibitory effects on the central nervous system. The effect
of midazolam premedication, as well as midazolam administration at the end of surgery, on
suppressing emergence agitation has been studied. However, the effect of midazolam on
emergence agitation is still controversial. This study aims to figure out the effect of
midazolam at the end of surgery on emergence agitation during the recovery period, and find
out the proper dose of midazolam with minimum disturbance to patient's emergence time.
Eligibility
Minimum age: 1 Year.
Maximum age: 13 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- American Society of Anesthesiologists physical status I and II patients
- Aged one to 13 years scheduled to undergo strabismus surgery under general anesthesia
- Willing to be assigned to any of the study intervention groups
Exclusion Criteria:
- Refusal by parents
- Neurological disease
- Developmental delay
- History of any previous surgery
- Airway disease
- American Society of Anesthesiologists physical status score of III or IV
Locations and Contacts
Department of Anaesthesiology and Pain Medicine Department; Korea University Anam Hospital, Seoul 136-705, Korea, Republic of
Additional Information
Starting date: July 2012
Last updated: January 3, 2013
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