NCT01318044

Brief Summary

Magnetic resonance imagining (MRI) in children requires sedation to achieve the degree of cooperation or immobilization, necessary to complete these procedures successfully. In this study the investigators analyze two most popular anesthetics used for this procedure, sodium thiopental and propofol. The aim of this study is to determine optimal dose of propofol and thiopental during MRI and to establish safety and efficacy of these drugs.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 18, 2011

Status Verified

January 1, 2011

Enrollment Period

3 months

First QC Date

March 11, 2011

Last Update Submit

March 17, 2011

Conditions

Complications

Keywords

thiopentalpropofolsedationMRI

Outcome Measures

Primary Outcomes (1)

  • presedation behavior

    Presedation behavior will be assessed on a 4-point scale, (by an anesthesiologist 1; who does not know which drug is administered): 1 = calm, cooperative; 2 = anxious but reasonable; 3 = anxious and not reasonable; 4 = crying or resisting. Categories 1 and 2 will be called "nondistressed behavior," and categories 3 and 4 will be defined as "distressed behavior."

    day of sedation (day 1)

Secondary Outcomes (4)

  • to determine optimal dose of propofol and thiopental during MRI

    day of sedation (day 1)

  • UMSS score

    day of sedation (day 1)

  • Side effects of sedation

    day of sedation (day 1)

  • recovery times

    day of sedation (day 1)

Study Arms (2)

Propofol group: propofol

ACTIVE COMPARATOR
Drug: Propofol and Thiopental

Thiopental group: thiopental

ACTIVE COMPARATOR
Drug: Propofol and Thiopental

Interventions

Propofol and ThiopentalDRUG

An initial bolus of 0.5 mg/kg of propofol will be administered over 1 minute. Supplementary boluses of propofol will be added until the UMSS score 3 are achieved. An initial bolus of 2 mg/kg of thiopental will be administered over 1 minute. Supplementary boluses of thiopental will be added until the UMSS score 3 are achieved

Also known as: Diprivan, Nesdonal
Propofol group: propofolThiopental group: thiopental

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patient is 6 months - 12 years old
  • Patient is scheduled for MRI at University Clinical center of Kosovo
  • Patients is ASA I/II
  • Patient meets criteria to receive either propofol or thiopental sedation
  • Patient's parent/guardian provides written consent

You may not qualify if:

  • Patients with ASA \> II
  • Patients with airway abnormalities
  • Patients with known allergies to the study drugs
  • Parent/guardian refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Center of Kosovo

Tirana, Kosovo, 10000, Albania

RECRUITING

Related Publications (1)

  • 1. Malvija S, Voepel -Lewis T, Eldevik OP, Rockwell DT, Wong JH, Tait AR. Sedation and general anaesthesia in children undergoing MRI and CT: adverse events and outcomes. Br J A naesth 2000; 84: 743-8. 2. Malviya S, Voepel-Lewis T, Tait AR, Merkel S, Tremper K, Naughton N. Depth of sedation in children undergoing computed tomography: validity and reliability of the University of Michigan Sedation Scale (UMSS). Br J Anaesth. 2002 ;88:241-5. 3. Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging. Anesth Analg. 2006;103:63-7.

    BACKGROUND

MeSH Terms

Interventions

PropofolThiopental

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsThiobarbituratesBarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Antigona Hasani, MD,MSC

    Anesthesiology and Reanimation

    STUDY CHAIR

Central Study Contacts

Antigona Hasani, MD, MSC

CONTACT

+37744402781antigona.hasani@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 18, 2011

Study Start

January 1, 2011

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

March 18, 2011

Record last verified: 2011-01

Locations

AL(1)