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

January 22, 2024 updated by: Santhita Pimonbut, Khon Kaen University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Muang
      • Khon Kaen, Muang, Thailand, 40002
        • Khon Kaen University
        • Contact:
        • Sub-Investigator:
          • Chakthip Suttinarakorn, M.D.
        • Sub-Investigator:
          • Wanatnarin Sorit, B.N.
        • Sub-Investigator:
          • Palardej Narrutto, B.N.
        • Principal Investigator:
          • Santhita Pimonbut, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group P
Receive 0.5 mg/kg of propofol intravenously at end of sevoflurane anesthesia
Drug: Propofol
recieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia
Placebo Comparator: group S
Receive saline intravenously at end of sevoflurane anesthesia
Drug: Normal saline
recieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of emergence agitation
Time Frame: at 5,10,15,20,25,30 minutes after extubation
at 5,10,15,20,25,30 minutes after extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complication
Time Frame: 2 hours after extubation
Nausea or vomiting, airway obstruction, laryngospasm, desaturation and apnea
2 hours after extubation
Use of rescue medication
Time Frame: 2 hours after extubation
use of ondansetron, atropine
2 hours after extubation
Emergence time
Time Frame: 2 hours after extubation
duration of emergence
2 hours after extubation
Length of stay in post anesthetic care unit
Time Frame: 2 hours after extubation
2 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Santhita Pimonbut, M.D., department of anesthesiology, faculty of medicine, Khonkaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE661348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected individual participant data

IPD Sharing Time Frame

6 month after publication

IPD Sharing Access Criteria

Researcher who required more information for further study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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