Clinical trial NCT01680471: A Study on the Effects of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Anesthesia Morbidity
Delirium on Emergence
Keywords: emergence agitation
midazolam
sevoflurane
strabismus
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Time of emergence
timeFrame: within the first 1hour after end of surgery
Secondary outcomes:
measure: Incidence of emergency agitation
timeFrame: From just after extubation until the discharge of PACU, assessed up to 1 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine Department; Korea University Anam Hospital
Study officials:
affiliation: Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
name: Eun Jung Cho, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
name: S.Z. Yoon, Professor
role: STUDY_DIRECTOR
References: