A Study on the Effects of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery

Korea University

Status: Completed

Conditions: Child; Anesthesia Morbidity; Delirium on Emergence

Treatments: Drug: Midazolam 0.03mg/kg; Drug: Midazolam 0.05mg/kg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01680471

ECho2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 1 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Midazolam 0.03mg/kg

Experimental group

Description:

This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery.

Treatment:

Drug: Midazolam 0.03mg/kg

Midazolam 0.05mg/kg

Experimental group

Description:

This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery.

Treatment:

Drug: Midazolam 0.05mg/kg

Placebo

Placebo Comparator group

Description:

This group will be injected intravenous normal saline five minutes before the end of surgery.

Treatment:

Drug: Placebo