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

Pediatric ALL Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528954
• Other study ID #: IndonesiaUAnes022
• Status: Completed
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Delirium
• Pediatric ALL
• Psychomotor Agitation

Intervention

Drug:
• Propofol
Those who received intravenous propofol

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (24)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: CNS Drugs. 2018 Sep;32(9):873. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5. Review. Erratum in: Paediatr Drugs. 2017 Jun;19(3):267. — View Citation

Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. — View Citation

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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):1625-30, table of contents. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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