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

Primary Purpose

Child, Anesthesia Morbidity, Delirium on Emergence

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Midazolam 0.03mg/kg
Midazolam 0.05mg/kg
Placebo
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child focused on measuring emergence agitation, midazolam, sevoflurane, strabismus

Eligibility Criteria

1 Year - 13 Years (Child)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Midazolam 0.03mg/kg

Midazolam 0.05mg/kg

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Time of emergence
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
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.

Full Information

First Posted
August 28, 2012
Last Updated
January 3, 2013
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01680471
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Anesthesia Morbidity, Delirium on Emergence
Keywords
emergence agitation, midazolam, sevoflurane, strabismus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Midazolam 0.03mg/kg
Arm Type
Experimental
Arm Description
This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery.
Arm Title
Midazolam 0.05mg/kg
Arm Type
Experimental
Arm Description
This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group will be injected intravenous normal saline five minutes before the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Midazolam 0.03mg/kg
Other Intervention Name(s)
MIDAZOLAM BUKWANG INJ 5mg/5ml
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Midazolam 0.05mg/kg
Other Intervention Name(s)
MIDAZOLAM BUKWANG INJ 5mg/5ml
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NORMAL SALINE INJ(Sodium chloride 9g/1000mL)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time of emergence
Description
The time of emergence is defined as time interval from the time of discontinuation of sevoflurane to the time of extubation.
Time Frame
within the first 1hour after end of surgery
Secondary Outcome Measure Information:
Title
Incidence of emergency agitation
Description
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.
Time Frame
From just after extubation until the discharge of PACU, assessed up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun Jung Cho, Resident
Organizational Affiliation
Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S.Z. Yoon, Professor
Organizational Affiliation
Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine Department; Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of

12. IPD Sharing Statement

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

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