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The goal of this clinical trial is to compare Efficacy of low dose propofol(0.5 mg/kg) vs placebo given at the end of sevoflurane anesthesia for prevention of emergence agitation in pediatric patient undergoing MRI scan. The main question it aims to answer is "Can low dose propofol reduce the incidence of emergence agitation after general anesthesia?" Participants will be given propofol 0.5 mg/kg or saline according to the allocated group at the completion of MRI scan
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group P | Experimental | Receive 0.5 mg/kg of propofol intravenously at end of sevoflurane anesthesia |
|
| group S | Placebo Comparator | Receive saline intravenously at end of sevoflurane anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | recieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of emergence agitation | at 5,10,15,20,25,30 minutes after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complication | Nausea or vomiting, airway obstruction, laryngospasm, desaturation and apnea | 2 hours after extubation |
| Use of rescue medication | use of ondansetron, atropine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Santhita Pimonbut, M.D. | Contact | 66943624641 | Santhita.p@kkumail.com |
| Name | Affiliation | Role |
|---|---|---|
| Santhita Pimonbut, M.D. | department of anesthesiology, faculty of medicine, Khonkaen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khon kaen University | Khon Kaen | Muang | 40002 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11473855 | Background | Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page. | |
| 8895263 | Background | Welborn LG, Hannallah RS, Norden JM, Ruttimann UE, Callan CM. Comparison of emergence and recovery characteristics of sevoflurane, desflurane, and halothane in pediatric ambulatory patients. Anesth Analg. 1996 Nov;83(5):917-20. doi: 10.1097/00000539-199611000-00005. |
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all collected individual participant data
6 month after publication
Researcher who required more information for further study
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RCT
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| Normal saline |
| Drug |
recieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia |
|
| 2 hours after extubation |
| Emergence time | duration of emergence | 2 hours after extubation |
| Length of stay in post anesthetic care unit | 2 hours after extubation |
| 18073548 | 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. |
| 12873918 | Background | Cravero JP, Beach M, Thyr B, Whalen K. The effect of small dose fentanyl on the emergence characteristics of pediatric patients after sevoflurane anesthesia without surgery. Anesth Analg. 2003 Aug;97(2):364-367. doi: 10.1213/01.ANE.0000070227.78670.43. |
| 25586124 | 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. |
| 33013031 | Background | Ramlan AAW, Pardede DKB, Marsaban AHMS, Hidayat J, Peddyandhari FS. Efficacy of 0.5 mg/kg of propofol at the end of anesthesia to reduce the incidence of emergence agitation in children undergoing general anesthesia with sevoflurane. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):177-181. doi: 10.4103/joacp.JOACP_257_19. Epub 2020 Jun 15. |
| 18095967 | Background | Abu-Shahwan I. Effect of propofol on emergence behavior in children after sevoflurane general anesthesia. Paediatr Anaesth. 2008 Jan;18(1):55-9. doi: 10.1111/j.1460-9592.2007.02376.x. |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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