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

NCT ID: NCT06218680

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-20

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emergence Agitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group P

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

group S

Receive saline intravenously at end of sevoflurane anesthesia

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propofol

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Santhita Pimonbut

Santhita Pimonbut

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Santhita Pimonbut, M.D.

Role: PRINCIPAL_INVESTIGATOR

department of anesthesiology, faculty of medicine, Khonkaen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Khon kaen University

Khon Kaen, Muang, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Santhita Pimonbut, M.D.

Role: CONTACT

66943624641

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Santhita Pimonbut, M.D.

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 11473855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8895263 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18073548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12873918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25586124 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33013031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18095967 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HE661348

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Scalp Nerve Block on Emergence Agitation
NCT02428283 COMPLETED PHASE4
Propofol in Emergence Agitation
NCT00535613 COMPLETED PHASE4
The PREVENT AGITATION Trial II - Children ≤1 Year
NCT05091242 RECRUITING PHASE2/PHASE3