Clinical trial NCT06218680: Efficacy of Low Dose Propofol Given at the End of Sevoflurane Anesthesia for Prevention of Emergence Agitation in Pediatric Patient Undergoing MRI Scan
Official title: Efficacy of Low Dose Propofol Given at the End of Sevoflurane Anesthesia for Prevention of Emergence Agitation in Pediatric Patient Undergoing MRI Scan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emergence Agitation
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 134
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Age 2-8 years
* ASA class I or II ,who schedule for MRI scan under sevoflurane anesthesia

Exclusion Criteria:

* Developmental delay
* Psychological and neurological disorders
* Abnormal airway
* Reactive airway disease
* Allergy to propofol, egg product
* Family history of malignant hyperthermia
* Need iv sedative medication before induction
* Obesity

Primary outcomes:
measure: incidence of emergence agitation
timeFrame: at 5,10,15,20,25,30 minutes after extubation
Secondary outcomes:
measure: Incidence of complication
timeFrame: 2 hours after extubation
measure: Use of rescue medication
timeFrame: 2 hours after extubation
measure: Emergence time
timeFrame: 2 hours after extubation
measure: Length of stay in post anesthetic care unit
timeFrame: 2 hours after extubation
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon kaen University
state: Muang
Study officials:
affiliation: department of anesthesiology, faculty of medicine, Khonkaen University
name: Santhita Pimonbut, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page.
citation: 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.
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.
citation: 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.
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.
citation: 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.
citation: 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.