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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eun Jung Cho, Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT01680471
First received: August 28, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Child
Anesthesia Morbidity
Delirium on Emergence
 Drug: Midazolam 0.03mg/kg
Drug: Midazolam 0.05mg/kg
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Delirium
U.S. FDA Resources

Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • Time of emergence [ Time Frame: within the first 1hour after end of surgery ] [ Designated as safety issue: No ]
    The time of emergence is defined as time interval from the time of discontinuation of sevoflurane to the time of extubation.


Secondary Outcome Measures:
  • Incidence of emergency agitation [ Time Frame: From just after extubation until the discharge of PACU, assessed up to 1 hour ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: July 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Midazolam 0.03mg/kg
This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery.
 Drug: Midazolam 0.03mg/kg

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 Name: MIDAZOLAM BUKWANG INJ 5mg/5ml
Experimental: Midazolam 0.05mg/kg
This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery.
 Drug: Midazolam 0.05mg/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.

Other Name: MIDAZOLAM BUKWANG INJ 5mg/5ml
Placebo Comparator: Placebo
This group will be injected intravenous normal saline five minutes before the end of surgery.
 Drug: Placebo

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

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

Ages Eligible for Study:   1 Year to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680471

Locations
Korea, Republic of
Department of Anaesthesiology and Pain Medicine Department; Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University Anam Hospital
Investigators
Principal Investigator: Eun Jung Cho, Resident Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
Study Director: S.Z. Yoon, Professor Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Eun Jung Cho, Anesthesiology and Pain Medicine Department, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT01680471     History of Changes
Other Study ID Numbers: ECho2012
Study First Received: August 28, 2012
Last Updated: January 3, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University Anam Hospital:
emergence agitation
midazolam
sevoflurane
strabismus

Additional relevant MeSH terms:
Delirium
Strabismus
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Anesthetics
Midazolam
Sevoflurane
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 19, 2013