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The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heather Frederick, Duke University
ClinicalTrials.gov Identifier:
NCT00990769
First received: October 5, 2009
Last updated: May 30, 2013
Last verified: May 2013
Results First Received: April 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor)
Condition: Emergence Agitation
Intervention: Other: Depth of anesthesia

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Parents or guardians of children undergoing ophthalmologic surgery were approached, when possible, at their pre-anesthesia evaluation visit. All eligible patients were notified about the study through fliers at their pre-operative visit, and eligible patients who were missed pre-operatively were approached for consent on the day of surgery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fifty-seven patients were approached for participation; of these, fourteen declined and three were unable to participate due to surgery cancellation or rescheduling.

Reporting Groups
  Description
High-normal BIS Depth of anesthesia is titrated to a BIS level of 55-60
Low-normal BIS Depth of anesthesia is titrated to a BIS level of 40-45

Participant Flow:   Overall Study
    High-normal BIS   Low-normal BIS
STARTED   22 [1]   18 [2] 
COMPLETED   22   18 
NOT COMPLETED   0   0 
[1] Signed consent and assigned to High-normal BIS
[2] Signed consent and assigned to Low-normal BIS



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High-normal BIS Depth of anesthesia is titrated to a BIS level of 55-60
Low-normal BIS Depth of anesthesia is titrated to a BIS level of 40-45
Total Total of all reporting groups

Baseline Measures
   High-normal BIS   Low-normal BIS   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   18   40 
Age 
[Units: Participants]
     
<=18 years   22   18   40 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 5.1  (2.3)   4.3  (1.4)   4.7  (1.9) 
Gender 
[Units: Participants]
     
Female   11   10   21 
Male   11   8   19 
Region of Enrollment 
[Units: Participants]
     
United States   22   18   40 


  Outcome Measures
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1.  Primary:   Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)   [ Time Frame: Within 30 minutes of arrival in recovery room ]

2.  Secondary:   Time to Emergence From Anesthesia   [ Time Frame: After the completion of surgery ]

3.  Secondary:   Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)   [ Time Frame: Within 30 minutes of arrival in recovery room ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Heather Frederick
Organization: Duke University Medical Center
phone: 919-812-6204
e-mail: heather.frederick@duke.edu



Responsible Party: Heather Frederick, Duke University
ClinicalTrials.gov Identifier: NCT00990769     History of Changes
Other Study ID Numbers: Pro00015531
Study First Received: October 5, 2009
Results First Received: April 10, 2013
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board