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

NCT03528954 | Completed

• 1 other identifier: IndonesiaUAnes022
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric ALL

Keywords

Emergence agitation; Propofol; General anesthesia

Outcome Measures

Primary Outcomes (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

  30 minutes after being admitted to post anesthesia care unit

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Received intravenous 0.5mg/kg propofol

Drug: Propofol

Control

NO INTERVENTION

Do not received intravenous 0.5 mg/kg propofol

Interventions

Propofol DRUG

Those who received intravenous propofol

Propofol

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (24)

• 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.

  PMID: 25917689 BACKGROUND

• 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.

  PMID: 25586124 BACKGROUND

• 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.

  PMID: 26251008 BACKGROUND

• 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.

  PMID: 18073548 BACKGROUND

• 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.

  PMID: 20047899 BACKGROUND

• 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.

  PMID: 28130755 BACKGROUND

• 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.

  PMID: 23800983 BACKGROUND

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

  PMID: 27798810 BACKGROUND

• 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.

  PMID: 26601849 BACKGROUND

• 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.

  PMID: 26290263 BACKGROUND

• 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.

  PMID: 24015133 BACKGROUND

• 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.

  PMID: 26444149 BACKGROUND

• 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.

  PMID: 18372935 BACKGROUND

• 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.

  PMID: 22078920 BACKGROUND

• 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.

  PMID: 24206937 BACKGROUND

• Aono J, Mamiya K, Manabe M. Preoperative anxiety is associated with a high incidence of problematic behavior on emergence after halothane anesthesia in boys. Acta Anaesthesiol Scand. 1999 May;43(5):542-4. doi: 10.1034/j.1399-6576.1999.430509.x.

  PMID: 10342002 BACKGROUND

• Beringer RM, Greenwood R, Kilpatrick N. Development and validation of the Pediatric Anesthesia Behavior score--an objective measure of behavior during induction of anesthesia. Paediatr Anaesth. 2014 Feb;24(2):196-200. doi: 10.1111/pan.12259. Epub 2013 Sep 19.

  PMID: 24103068 BACKGROUND

• Burke CN, Voepel-Lewis T, Hadden S, DeGrandis M, Skotcher S, D'Agostino R, Walton S, Malviya S. Parental presence on emergence: effect on postanesthesia agitation and parent satisfaction. J Perianesth Nurs. 2009 Aug;24(4):216-21. doi: 10.1016/j.jopan.2009.03.014.

  PMID: 19647657 BACKGROUND

• Singh R, Kharbanda M, Sood N, Mahajan V, Chatterji C. Comparative evaluation of incidence of emergence agitation and post-operative recovery profile in paediatric patients after isoflurane, sevoflurane and desflurane anaesthesia. Indian J Anaesth. 2012 Mar;56(2):156-61. doi: 10.4103/0019-5049.96325.

  PMID: 22701207 BACKGROUND

• Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.

  PMID: 12760985 BACKGROUND

• Key KL, Rich C, DeCristofaro C, Collins S. Use of propofol and emergence agitation in children: a literature review. AANA J. 2010 Dec;78(6):468-73.

  PMID: 21309294 BACKGROUND

• Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.

  PMID: 15114210 BACKGROUND

• Kim MS, Moon BE, Kim H, Lee JR. Comparison of propofol and fentanyl administered at the end of anaesthesia for prevention of emergence agitation after sevoflurane anaesthesia in children. Br J Anaesth. 2013 Feb;110(2):274-80. doi: 10.1093/bja/aes382. Epub 2012 Oct 26.

  PMID: 23103775 BACKGROUND

• Liu GY, Chen ZQ, Zhang ZW. Comparative study of emergence agitation between isoflurane and propofol anesthesia in adults after closed reduction of distal radius fracture. Genet Mol Res. 2014 Jan 24;13(4):9285-91. doi: 10.4238/2014.January.24.9.

  PMID: 24615079 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Emergence Delirium

Interventions

Propofol

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 18, 2018
• Study Start: May 31, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

ID (1)