Efficacy of Low Dose Propofol Given at the End of Sevoflurane Anesthesia for Prevention of Emergence Agitation in Pediatric Patient Undergoing MRI Scan

Emergence Agitation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06218680
• Other study ID #: HE661348
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2024
• Source: Khon Kaen University
• Contact: Santhita Pimonbut, M.D.
• Phone: 66943624641
• Email: Santhita.p[@]kkumail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Propofol
recieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia
• Normal saline
recieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia

Locations

Country	Name	City	State
Thailand	Khon kaen University	Khon Kaen	Muang

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

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. — 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. doi: 10.1097/01.anes.0000287009.46896.a7. — 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

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of emergence agitation		at 5,10,15,20,25,30 minutes after extubation
Secondary	Incidence of complication	Nausea or vomiting, airway obstruction, laryngospasm, desaturation and apnea	2 hours after extubation
Secondary	Use of rescue medication	use of ondansetron, atropine	2 hours after extubation
Secondary	Emergence time	duration of emergence	2 hours after extubation
Secondary	Length of stay in post anesthetic care unit		2 hours after extubation