- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03528954
Propofol to Reduce the Incidence of Postanesthetic Emergence Agitation in Pediatric Patients Under General Anesthesia
February 4, 2019 updated by: Andi Ade Wijaya Ramlan, Indonesia University
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 10430
- Cipto Mangunkusumo Cental National Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 5 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Propofol
Received intravenous 0.5mg/kg propofol
|
Those who received intravenous propofol
|
NO_INTERVENTION: Control
Do not received intravenous 0.5 mg/kg propofol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of emergence agitation
Time Frame: 30 minutes after being admitted to post anesthesia care unit
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 31, 2018
Primary Completion (ACTUAL)
August 31, 2018
Study Completion (ACTUAL)
August 31, 2018
Study Registration Dates
First Submitted
April 27, 2018
First Submitted That Met QC Criteria
May 17, 2018
First Posted (ACTUAL)
May 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2019
Last Update Submitted That Met QC Criteria
February 4, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dyskinesias
- Psychomotor Disorders
- Delirium
- Psychomotor Agitation
- Emergence Delirium
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Hypnotics and Sedatives
- Propofol
Other Study ID Numbers
- IndonesiaUAnes022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric ALL
-
University of BirminghamCompletedCancer | Pediatric ALL | Pediatric Solid Tumor | Pediatric AMLUnited Kingdom, Australia, Netherlands
-
Samsung Medical CenterMinistry of Health, Republic of KoreaRecruitingRelapsed Pediatric AML | Refractory Pediatric AML | Relapsed Pediatric Solid Tumor | Refractory Pediatric Solid TumorKorea, Republic of
-
National Institute of Allergy and Infectious Diseases...Clinical Trials in Organ Transplantation in ChildrenCompletedPediatric Heart Transplantation | Pediatric Heart Transplant Recipients | Pediatric Cardiac TransplantationUnited States
-
University Hospital, Strasbourg, FranceTerminatedPediatric Lung Ultrasound | Pediatric Chest Radiography | Pediatric Lung DiagnosisFrance
-
TC Erciyes UniversityCompletedPediatric Cancer | Pediatric Brain Tumor | Pediatric Solid TumorTurkey
-
National Institute of Allergy and Infectious Diseases...National Heart, Lung, and Blood Institute (NHLBI)TerminatedPediatric Heart Transplantation | Pediatric Heart Transplant RecipientsUnited States, Canada
-
University of CalgaryCanadian Institutes of Health Research (CIHR); Alberta Children's Hospital; Stollery... and other collaboratorsNot yet recruitingPediatric Cancer | Pediatric Hematology
-
Children's Healthcare of AtlantaEmory UniversityCompletedPediatric Preoperative Anxiety, Pediatric CopingUnited States
-
Hospital Moinhos de VentoNot yet recruitingAdolescent | Telemedicine | Critical Care | Pediatric | Intensive Care Units, Pediatric
-
Samsung Medical CenterMinistry of Health, Republic of KoreaNot yet recruitingRelapsed Pediatric Solid Tumor | Refractory Pediatric Solid TumorKorea, Republic of
Clinical Trials on Propofol
-
Hopital FochCompleted
-
Konkuk University Medical CenterCompletedCoronary Artery Disease | Valvular Heart DiseaseKorea, Republic of
-
University Medical Center GroningenCompletedAnesthesia | Hemodynamic Instability | Interaction | Disorder of Oxygen TransportNetherlands
-
Asan Medical CenterCompletedPopulation Pharmacokinetics/Pharmacodynamics (PK/PD) of Microemulsion Propofol in Healthy VolunteersHealthyKorea, Republic of
-
Tiva GroupMedtronic - MITGCompleted
-
Pontificia Universidad Catolica de ChileCompletedSurgery | Anesthesia | Depth of Anesthesia | NeonateChile
-
Mansoura UniversityCompleted
-
KVG Medical College and HospitalUnknown
-
Acibadem UniversityCompleted