Clinical trial NCT03528954: Propofol to Reduce the Incidence of Postanesthetic Emergence Agitation in Pediatric Patients Under General Anesthesia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric ALL
Keywords: Emergence agitation
Propofol
General anesthesia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 54
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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

Primary outcomes:
measure: Incidence of emergence agitation
timeFrame: 30 minutes after being admitted to post anesthesia care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
References:
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