A Study on the Effects of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery
Condition: Child; Anesthesia Morbidity; Delirium on Emergence
MeSH terms: Delirium; Strabismus; Emergence Delirium
Study type: Interventional

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.
    

Intervention name(s): Midazolam 0.03mg/kg; Midazolam 0.05mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery.
If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg.; This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery.
If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg.; This group will be injected intravenous normal saline five minutes before the end of surgery.
If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg.
Other intervention name(s): MIDAZOLAM BUKWANG INJ 5mg/5ml; MIDAZOLAM BUKWANG INJ 5mg/5ml; NORMAL SALINE INJ(Sodium chloride 9g/1000mL)
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: emergence agitation; midazolam; sevoflurane; strabismus