Thiopental Versus Propofol During Magnetic Resonance Imagining in Children: Something Old, Something New
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| ClinicalTrials.gov Identifier: NCT01318044 |
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Recruitment Status : Unknown
Verified January 2011 by University Clinical Centre of Kosova.
Recruitment status was: Recruiting
First Posted : March 18, 2011
Last Update Posted : March 18, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Complications | Drug: Propofol and Thiopental | Phase 1 Phase 2 |
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 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 |
| 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:
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| 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:
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- 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."
- 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.
- UMSS score [ Time Frame: day of sedation (day 1) ]
- 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.
- 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).
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| Ages Eligible for Study: | 6 Months to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318044
| Contact: Antigona Hasani, MD, MSC | +37744402781 | antigona.hasani@gmail.com |
| Albania | |
| University Clinical Center of Kosovo | Recruiting |
| Tirana, Kosovo, Albania, 10000 | |
| Contact: Aban Gjonbalaj, MD +38138500600 gjonbalaj_a@hotmail.com | |
| Study Chair: | Antigona Hasani, MD,MSC | Anesthesiology and Reanimation |
Publications:
| 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 Key Record Dates |
| Last Update Posted: | March 18, 2011 |
| Last Verified: | January 2011 |
Keywords provided by University Clinical Centre of Kosova:
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thiopental propofol sedation MRI |
Additional relevant MeSH terms:
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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 |