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OpenTrials
Completed

NCT Number: NCT03528954

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Those who received intravenous propofol

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 18, 2018
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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