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Pediatric ALLNCT03528954

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

A study testing Propofol in people with Pediatric ALL, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 1 year to 5 years
Conditions the study is for
Pediatric ALL
What is being tested?
Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteIndonesia
Study dates
31 May 2018to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Cental National Hospital

    Jakarta, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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

Read the 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
Being tested
Propofol
Keywords
Emergence agitation, Propofol, General anesthesia
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    Those who received intravenous propofol

Study groups in NCT03528954
Study groupRoleWhat they receive
PropofolActive comparatorReceived intravenous 0.5mg/kg propofol
Receives: Drug: Propofol
ControlNo interventionDo not received intravenous 0.5 mg/kg propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of emergence agitation

    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

    Measured: 30 minutes after being admitted to post anesthesia care unit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2018
  2. Study start31 May 2018
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03528954
Sponsor's protocol ID
IndonesiaUAnes022
Status last verified
Feb 2019
First submitted
27 Apr 2018
Last updated
6 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van Hoff SL, O'Neill ES, Cohen LC, Collins BA. Does a prophylactic dose of propofol reduce emergence agitation in children receiving anesthesia? A systematic review and meta-analysis. Paediatr Anaesth. 2015 Jul;25(7):668-76. doi: 10.1111/pan.12669. Epub 2015 Apr 27.

    PubMed 25917689

  • Costi D, Ellwood J, Wallace A, Ahmed S, Waring L, Cyna A. Transition to propofol after sevoflurane anesthesia to prevent emergence agitation: a randomized controlled trial. Paediatr Anaesth. 2015 May;25(5):517-23. doi: 10.1111/pan.12617. Epub 2015 Jan 13.

    PubMed 25586124

  • Jiang S, Liu J, Li M, Ji W, Liang J. The efficacy of propofol on emergence agitation--a meta-analysis of randomized controlled trials. Acta Anaesthesiol Scand. 2015 Nov;59(10):1232-45. doi: 10.1111/aas.12586. Epub 2015 Aug 6.

    PubMed 26251008

  • Aouad MT, Yazbeck-Karam VG, Nasr VG, El-Khatib MF, Kanazi GE, Bleik JH. A single dose of propofol at the end of surgery for the prevention of emergence agitation in children undergoing strabismus surgery during sevoflurane anesthesia. Anesthesiology. 2007 Nov;107(5):733-8. doi: 10.1097/01.anes.0000287009.46896.a7.

    PubMed 18073548

  • Dahmani S, Stany I, Brasher C, Lejeune C, Bruneau B, Wood C, Nivoche Y, Constant I, Murat I. Pharmacological prevention of sevoflurane- and desflurane-related emergence agitation in children: a meta-analysis of published studies. Br J Anaesth. 2010 Feb;104(2):216-23. doi: 10.1093/bja/aep376. Epub 2010 Jan 3.

    PubMed 20047899

  • Huett C, Baehner T, Erdfelder F, Hoehne C, Bode C, Hoeft A, Ellerkmann RK. Prevention and Therapy of Pediatric Emergence Delirium: A National Survey. Paediatr Drugs. 2017 Apr;19(2):147-153. doi: 10.1007/s40272-017-0212-x.

    PubMed 28130755

  • Kanaya A, Kuratani N, Satoh D, Kurosawa S. Lower incidence of emergence agitation in children after propofol anesthesia compared with sevoflurane: a meta-analysis of randomized controlled trials. J Anesth. 2014 Feb;28(1):4-11. doi: 10.1007/s00540-013-1656-y. Epub 2013 Jun 26.

    PubMed 23800983

  • Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5.

    PubMed 27798810

  • Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24.

    PubMed 26601849

  • Chidambaran V, Costandi A, D'Mello A. Propofol: a review of its role in pediatric anesthesia and sedation. CNS Drugs. 2015 Jul;29(7):543-63. doi: 10.1007/s40263-015-0259-6.

    PubMed 26290263

  • Ali MA, Abdellatif AA. Prevention of sevoflurane related emergence agitation in children undergoing adenotonsillectomy: A comparison of dexmedetomidine and propofol. Saudi J Anaesth. 2013 Jul;7(3):296-300. doi: 10.4103/1658-354X.115363.

    PubMed 24015133

  • Makkar JK, Bhatia N, Bala I, Dwivedi D, Singh PM. A comparison of single dose dexmedetomidine with propofol for the prevention of emergence delirium after desflurane anaesthesia in children. Anaesthesia. 2016 Jan;71(1):50-7. doi: 10.1111/anae.13230. Epub 2015 Oct 7.

    PubMed 26444149

  • Silva LM, Braz LG, Modolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763.

    PubMed 18372935

  • Smith HA, Fuchs DC, Pandharipande PP, Barr FE, Ely EW. Delirium: an emerging frontier in the management of critically ill children. Anesthesiol Clin. 2011 Dec;29(4):729-50. doi: 10.1016/j.anclin.2011.09.011.

    PubMed 22078920

  • Maldonado JR. Neuropathogenesis of delirium: review of current etiologic theories and common pathways. Am J Geriatr Psychiatry. 2013 Dec;21(12):1190-222. doi: 10.1016/j.jagp.2013.09.005.

    PubMed 24206937

Questions about this trial

What is this clinical trial studying?

A study testing Propofol in people with Pediatric ALL, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of emergence agitation (time frame: 30 minutes after being admitted to post anesthesia care unit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03528954, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.

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