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

U

University of Indonesia (UI)

Status

Completed

Conditions

Pediatric ALL

Treatments

Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT03528954
IndonesiaUAnes022

Details and patient eligibility

About

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

Full 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.

Enrollment

54 patients

Sex

All

Ages

1 to 5 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

54 participants in 2 patient groups

Propofol
Active Comparator group
Description:
Received intravenous 0.5mg/kg propofol
Treatment:
Drug: Propofol
Control
No Intervention group
Description:
Do not received intravenous 0.5 mg/kg propofol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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