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Propofol to Reduce the Incidence of Postanesthetic Emergence Agitation in Pediatric Patients Under General Anesthesia

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: NCT03528954
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Andi Ade Wijaya Ramlan, Indonesia University

Study Description
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Brief Summary:
This study aimed to know the effectivity of 0.5 mg/kg propofol in the end of anesthesia to reduce the incidence of postanesthetic emergence agitation in pediatric patients under general inhalation anesthesia

Condition or disease Intervention/treatment Phase
Pediatric ALL Drug: Propofol Not Applicable

Detailed Description:
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups; propofol and control. Non-invasive blood pressure monitor, electrocardiogram (ECG), pulse-oxymetry, and capnograph were set on the subjects in the operation room. Induction and maintenance of anesthesia will use sevoflurane. Mechanical ventilation will be given to maintaining end-tidal carbon dioxide 35 to 40 mmHg. After surgery, patient will be given intravenously 15mg/kg acetaminophen, 0.05mg/kg neostigmine, and 0.02 mg/kg atropine. Patient will also be given propofol 0.5 mg/kg on propofol group while no propofol will be given on control group. 30 minutes after patient was admitted to post-anesthesia care unit, patient will be evaluated for emergence agitation using Aono scale and Pediatric Anesthesia Emergence Delirium scale. The incidence of emergence agitation, hypotension, and desaturation will be treated accordingly.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectivity of 0.5 mg/kg Propofol in the End of Anesthesia to Reduce the Incidence of Postanesthetic Emergence Agitation in Pediatric Patients Under General Inhalation Anesthesia
Actual Study Start Date : May 31, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Propofol
Received intravenous 0.5mg/kg propofol
 Drug: Propofol
Those who received intravenous propofol
No Intervention: Control
Do not received intravenous 0.5 mg/kg propofol


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of emergence agitation [ Time Frame: 30 minutes after being admitted to post anesthesia care unit ]
    Evaluated using Aono scale and Pediatric Anesthesia Emergence Delirium (PAED) scale. Patients with ≥3 on Aono scale AND ≥10 on PAED scale are diagnosed as emergence agitation


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient undergoing non-emergency surgery with general anesthesia
  • Patient using sevoflurane as anesthetic agent
  • Patient aged 1 - 5 years old
  • American Society of Anesthesiologists (ASA) physical status 1 - 2
  • Patient family signed the informed consent to be included in the study

Exclusion Criteria:

  • Patient that will undergo ophthalmologic and otorhinolaryngologic surgery
  • Patient that will require post operation stay in Intensive Care Unit
  • Patient with psychological and neurological problem
  • Patient with developmental delay
  • Patient using sedative drugs
  • Patient with allergy to propofol
  • Patient or patient family with history of malignant hyperthermia
  • Patient with difficulty on intubation and ventilation
  • Patient with cardiovascular disease
  • Patient with hemodynamic instability
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03528954


Locations
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Indonesia
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
More Information
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Publications:

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Responsible Party: Andi Ade Wijaya Ramlan, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03528954    
Other Study ID Numbers: IndonesiaUAnes022
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Andi Ade Wijaya Ramlan, Indonesia University:
Emergence agitation
Propofol
General anesthesia
Additional relevant MeSH terms:
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Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Delirium
Confusion
Postoperative Complications
 Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics