Complications Clinical Trial
Official title:
Thiopental Versus Propofol During Magnetic Resonance Imagining in Children
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 12 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Albania | University Clinical Center of Kosovo | Tirana | Kosovo |
Lead Sponsor | Collaborator |
---|---|
University Clinical Centre of Kosova |
Albania,
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | to determine optimal dose of propofol and thiopental during MRI | 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. | day of sedation (day 1) | No |
Secondary | UMSS score | day of sedation (day 1) | No | |
Secondary | Side effects of sedation | Side effects (apnea, nausea, vomiting, laryngospasm, emergence agitation) could occur during and after sedation will be recorded. | day of sedation (day 1) | No |
Secondary | recovery times | 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). | day of sedation (day 1) | No |
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