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

Not Applicable

Completed

• Conditions: Pediatric ALL
• Interventions: Drug: Propofol

• Registration Number: NCT03528954
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study First Submitted: 2018-04-27
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Study Start: 2018-05-31
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-04
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Received intravenous 0.5mg/kg propofol

Primary Outcome Measures

Name	Time	Method
Incidence of emergence agitation	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

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia