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

NCT ID: NCT03528954

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2018-08-31

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.

Conditions

Pediatric ALL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Propofol

Received intravenous 0.5mg/kg propofol

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Those who received intravenous propofol

Control

Do not received intravenous 0.5 mg/kg propofol

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Propofol

Those who received intravenous propofol

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Andi Ade Wijaya Ramlan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

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Other Identifiers

IndonesiaUAnes022

Identifier Type: -

Identifier Source: org_study_id