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Emergence Agitation in Pediatric Strabismus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03807011
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Eun Kyung Choi, Yeungnam University College of Medicine

Study Description
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Brief Summary:
This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.

Condition or disease Intervention/treatment Phase
Emergence Agitation Drug: fentanyl group Drug: remifentanil group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery
Actual Study Start Date : July 7, 2017
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 5, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: fentanyl
A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction
 Drug: fentanyl group
fentanyl 2 μg/kg
Active Comparator: remifentanil
Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery
 Drug: remifentanil group
remifentanil 0.2 μg/kg/min


Outcome Measures
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Primary Outcome Measures :
  1. incidence of postoperative agitation [ Time Frame: 5 minutes in the recovery room ]
    0=none; 1=occur

  2. incidence of postoperative agitation [ Time Frame: 30 minutes in the recovery room ]
    0=none; 1=occur

  3. severity of postoperative agitation [ Time Frame: 5 minutes in the recovery room ]
    Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)

  4. severity of postoperative agitation [ Time Frame: 30 minutes in the recovery room ]
    Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing elective subumbilical surgery,
  • physical status was American Society of Anesthesiologists (ASA) class 1 or 2

Exclusion Criteria:

  • history of airway problem,
  • upper respiratory tract infection within 2 weeks,
  • developmental delay,
  • neurological or psychological disease,
  • history of allergy to the drugs in our protocol were excluded in this study.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807011


Locations
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Korea, Republic of
Eun kyung Choi
Daegu, Korea (the Republic Of), Korea, Republic of, 41944
Yeungnam University Hospital
Daegu, Nam-gu, Daegu, Korea, Republic of, 42415
Sponsors and Collaborators
Yeungnam University College of Medicine
More Information
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Responsible Party: Eun Kyung Choi, Professor, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT03807011    
Other Study ID Numbers: YUMC 2017-04-071
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eun Kyung Choi, Yeungnam University College of Medicine:
Emergence Agitation
fentanyl
remifentanil
children
Additional relevant MeSH terms:
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Psychomotor Agitation
Strabismus
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Delirium
Confusion
Postoperative Complications
Pathologic Processes
 Neurocognitive Disorders
Mental Disorders
Fentanyl
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics