Clinical trial

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

Name

HE661348

Description

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

Trial arms

Trial start

2024-01-20

Estimated PCD

2025-04-30

Trial end

2025-04-30

Status

Not yet recruiting

Treatment

Propofol

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

Arms:

group P

Normal saline

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

Arms:

group S

Size

134

Primary endpoint

incidence of emergence agitation

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 134, 'type': 'ESTIMATED'}}

Updated at

2024-01-23

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug