Thiopental Versus Propofol During Magnetic Resonance Imagining in Children: Something Old, Something New

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Clinical Centre of Kosova.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Clinical Centre of Kosova
ClinicalTrials.gov Identifier:
NCT01318044
First received: March 11, 2011
Last updated: March 17, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Complications
Drug: Propofol and Thiopental
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thiopental Versus Propofol During Magnetic Resonance Imagining in Children

Resource links provided by NLM:


Further study details as provided by University Clinical Centre of Kosova:

Primary Outcome Measures:
  • presedation behavior [ Time Frame: day of sedation (day 1) ] [ Designated as safety issue: No ]
    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."


Secondary Outcome Measures:
  • to determine optimal dose of propofol and thiopental during MRI [ Time Frame: day of sedation (day 1) ] [ Designated as safety issue: No ]
    The UMSS assigns a score of 0-4 based on the clinical assessment of the level of sedation as follows: 0 = awake and alert; 1 = minimally sedated: tired/sleepy, appropriate response to verbal conversation and/or sound; 2 = moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation or a simple verbal command; 3 = deeply sedated: deep sleep, arousable only with significant physical stimulation, and 4 = unarousable. Scores 3 will be accepted as procedural sedation and 4 will be accepted as deep sedation.

  • UMSS score [ Time Frame: day of sedation (day 1) ] [ Designated as safety issue: No ]
  • Side effects of sedation [ Time Frame: day of sedation (day 1) ] [ Designated as safety issue: No ]
    Side effects (apnea, nausea, vomiting, laryngospasm, emergence agitation) could occur during and after sedation will be recorded.

  • recovery times [ Time Frame: day of sedation (day 1) ] [ Designated as safety issue: No ]
    Recovery time will be accepted as the period of time between the ends of MRI scan and reaching a UMSS score of 2 (by an anesthesiologist 2).


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol group: propofol Drug: Propofol and Thiopental

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

Other Names:
  • Diprivan
  • Nesdonal
Active Comparator: Thiopental group: thiopental Drug: Propofol and Thiopental

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

Other Names:
  • Diprivan
  • Nesdonal

Detailed Description:

This prospective, randomize, double-blind study will include 100 children, aged 6 month-12 years with ASA physical status I-II.

Children older than 3 years of age shall consume nothing by mouth (NPO) for solids and milk for at least 8 hours and children 6 months-3 years of age are NPO for solids and milk for 6 hours. Children will be allowed to receive breast milk until 4 hours before the beginning of the sedation. All the children will be allowed to take clear liquids up until 2 hours before the beginning of the sedation. To facilitate IV drug administration, EMLA cream will be applied on the dorsum of both hands 1 h before transfer to the preparation room.

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." Patients will receive: group I; propofol 0.5 mg/kg or group II; thiopental 2.0 mg/kg, for anesthetic induction. After initial dose of the drug the sedation level of the children will be measured by the anesthesiologist 2 using the University of Michigan Sedation Scale (UMSS). The UMSS assigns a score of 0-4 based on the clinical assessment of the level of sedation as follows: 0 = awake and alert; 1 = minimally sedated: tired/sleepy, appropriate response to verbal conversation and/or sound; 2 = moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation or a simple verbal command; 3 = deeply sedated: deep sleep, arousable only with significant physical stimulation, and 4 = unarousable. Scores 3 will be accepted as procedural sedation and 4 will be accepted as deep sedation.

If a UMSS score of 3 will not be achieved after initial dose of propofol and thiopental, supplementary boluses of drugs will be added.

Mean arterial blood pressure (MAP), heart rate (HR), peripheral oxygen saturation (Spo2), and respiratory rate (RR) will be monitored continuously and be recorded at 5-min intervals during the study period by anesthesiologist 1. Patients will be allowed to breathe spontaneously without an artificial airway throughout the procedure. Oxygen will be administered via facemask.

Quality of the MRI will be evaluated by a radiologist using a three-point scale (1 = no motion; 2 = minor movement; 3 = major movement necessitating another scan).

Recovery time will be accepted as the period of time between the ends of MRI scan and reaching a UMSS score of 2 (by an anesthesiologist 2).

Side effects (apnea, nausea, vomiting, laryngospasm, emergence agitation) could occur during and after sedation will be recorded.

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with ASA > II
  • Patients with airway abnormalities
  • Patients with known allergies to the study drugs
  • Parent/guardian refusal of participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318044

Contacts
Contact: Antigona Hasani, MD, MSC +37744402781 antigona.hasani@gmail.com

Locations
Albania
University Clinical Center of Kosovo Recruiting
Tirana, Kosovo, Albania, 10000
Contact: Aban Gjonbalaj, MD    +38138500600    gjonbalaj_a@hotmail.com   
Sponsors and Collaborators
University Clinical Centre of Kosova
Investigators
Study Chair: Antigona Hasani, MD,MSC Anesthesiology and Reanimation
  More Information

No publications provided

Responsible Party: Antigona Hasani, University Clinical Center of Kosovo
ClinicalTrials.gov Identifier: NCT01318044     History of Changes
Other Study ID Numbers: UCCK-30
Study First Received: March 11, 2011
Last Updated: March 17, 2011
Health Authority: Kosovo: Medical Faculty Ethical Board

Keywords provided by University Clinical Centre of Kosova:
thiopental
propofol
sedation
MRI
Sedation

Additional relevant MeSH terms:
Propofol
Thiopental
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014