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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Complications	Drug: Propofol and Thiopental	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Thiopental Versus Propofol During Magnetic Resonance Imagining in Children
Study Start Date :	January 2011
Estimated Primary Completion Date :	April 2011
Estimated Study Completion Date :	May 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. presedation behavior [ Time Frame: day of sedation (day 1) ]
   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 :

1. to determine optimal dose of propofol and thiopental during MRI [ Time Frame: day of sedation (day 1) ]
   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.
2. UMSS score [ Time Frame: day of sedation (day 1) ]
3. Side effects of sedation [ Time Frame: day of sedation (day 1) ]
   Side effects (apnea, nausea, vomiting, laryngospasm, emergence agitation) could occur during and after sedation will be recorded.
4. recovery times [ Time Frame: day of sedation (day 1) ]
   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).

Eligibility Criteria

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Ages Eligible for Study:	6 Months to 12 Years (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Responsible Party:	Antigona Hasani, University Clinical Center of Kosovo
ClinicalTrials.gov Identifier:	NCT01318044 History of Changes
Other Study ID Numbers:	UCCK-30
First Posted:	March 18, 2011
Last Update Posted:	March 18, 2011
Last Verified:	January 2011

Keywords provided by University Clinical Centre of Kosova:

thiopental; propofol; sedation; MRI

Additional relevant MeSH terms:

Propofol; Thiopental; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General	Anesthetics; Anticonvulsants; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action