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

NCT06218680 | Unknown DMC

• 1 other identifier: HE661348
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• incidence of emergence agitation

  at 5,10,15,20,25,30 minutes after extubation

Secondary Outcomes (4)

• Incidence of complication

  2 hours after extubation

• Use of rescue medication

  2 hours after extubation

• Emergence time

  2 hours after extubation

• Length of stay in post anesthetic care unit

  2 hours after extubation

Study Arms (2)

group P

EXPERIMENTAL

Receive 0.5 mg/kg of propofol intravenously at end of sevoflurane anesthesia

Drug: Propofol

group S

PLACEBO COMPARATOR

Receive saline intravenously at end of sevoflurane anesthesia

Drug: Normal saline

Interventions

Propofol DRUG

recieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia

group P

Normal saline DRUG

recieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia

group S

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon kaen University

Khon Kaen, Muang, 40002, Thailand

Location

Related Publications (7)

• Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page.

  PMID: 11473855 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.

  PMID: 8895263 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.

  PMID: 18073548 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.

  PMID: 12873918 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.

  PMID: 25586124 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.

  PMID: 33013031 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.

  PMID: 18095967 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Santhita Pimonbut, M.D.

  department of anesthesiology, faculty of medicine, Khonkaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santhita Pimonbut, M.D.

CONTACT

66943624641; Santhita.p@kkumail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Santhita Pimonbut

Model Details: RCT

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: January 20, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 month after publication
• Access Criteria: Researcher who required more information for further study

Locations

TH (1)