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NCT Number: NCT01680471

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

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.

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Key information

Conditions

Child Anesthesia Morbidity Confusion Cranial Nerve Diseases Delirium Delirium on Emergence Emergence Delirium Eye Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Ocular Motility Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Strabismus

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Pain Medicine Department; Korea University Anam Hospital

Seoul, 136-705, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midazolam 0.03mg/kg

Drug

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.

Other names: MIDAZOLAM BUKWANG INJ 5mg/5ml

Midazolam 0.05mg/kg

Drug

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.

Other names: MIDAZOLAM BUKWANG INJ 5mg/5ml

Placebo

Drug

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 names: NORMAL SALINE INJ(Sodium chloride 9g/1000mL)

Primary outcomes

  1. Time of emergence

    Time frame: within the first 1hour after end of surgery

    The time of emergence is defined as time interval from the time of discontinuation of sevoflurane to the time of extubation.

Secondary outcomes

  1. Incidence of emergency agitation

    Time frame: From just after extubation until the discharge of PACU, assessed up to 1 hour

    Agitation is assessed immediately after extubation, and continuously thereafter until participants are calm. Emergence agitation is evaluated using the four-point emergence scale and the pediatric anesthesia emergence delirium scale. The highest scores are recorded.

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

Comparative Study on the Effects of Capacities of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery : a Randomized Double- Blinded Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2012
Registry last updated
Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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