search
Back to results

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

Primary Purpose

Pediatric ALL

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Propofol
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pediatric ALL focused on measuring Emergence agitation, Propofol, General anesthesia

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cipto Mangunkusumo Cental National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Propofol

Control

Arm Description

Received intravenous 0.5mg/kg propofol

Do not received intravenous 0.5 mg/kg propofol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2018
Last Updated
February 4, 2019
Sponsor
Indonesia University
search

1. Study Identification

Unique Protocol Identification Number
NCT03528954
Brief Title
Propofol to Reduce the Incidence of Postanesthetic Emergence Agitation in Pediatric Patients Under General Anesthesia
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric ALL
Keywords
Emergence agitation, Propofol, General anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Received intravenous 0.5mg/kg propofol
Arm Title
Control
Arm Type
No Intervention
Arm Description
Do not received intravenous 0.5 mg/kg propofol
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Those who received intravenous propofol
Primary Outcome Measure Information:
Title
Incidence of emergence agitation
Description
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
Time Frame
30 minutes after being admitted to post anesthesia care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cipto Mangunkusumo Cental National Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25917689
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.
Results Reference
background
PubMed Identifier
25586124
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.
Results Reference
background
PubMed Identifier
26251008
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.
Results Reference
background
PubMed Identifier
18073548
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. doi: 10.1097/01.anes.0000287009.46896.a7.
Results Reference
background
PubMed Identifier
20047899
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.
Results Reference
background
PubMed Identifier
28130755
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.
Results Reference
background
PubMed Identifier
23800983
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.
Results Reference
background
PubMed Identifier
27798810
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. Erratum In: Paediatr Drugs. 2017 Jun;19(3):267.
Results Reference
background
PubMed Identifier
26601849
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.
Results Reference
background
PubMed Identifier
26290263
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. Erratum In: CNS Drugs. 2018 Sep;32(9):873.
Results Reference
background
PubMed Identifier
24015133
Citation
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.
Results Reference
background
PubMed Identifier
26444149
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.
Results Reference
background
PubMed Identifier
18372935
Citation
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.
Results Reference
background
PubMed Identifier
22078920
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.
Results Reference
background
PubMed Identifier
24206937
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.
Results Reference
background
PubMed Identifier
10342002
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. doi: 10.1034/j.1399-6576.1999.430509.x.
Results Reference
background
PubMed Identifier
24103068
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.
Results Reference
background
PubMed Identifier
19647657
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.
Results Reference
background
PubMed Identifier
22701207
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.
Results Reference
background
PubMed Identifier
12760985
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):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.
Results Reference
background
PubMed Identifier
21309294
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.
Results Reference
background
PubMed Identifier
15114210
Citation
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.
Results Reference
background
PubMed Identifier
23103775
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.
Results Reference
background
PubMed Identifier
24615079
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs