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ISRCTN
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ISRCTN07742712
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ClinicalTrials.gov identifier
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Public title
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Effect of mivacurium 200 and 250 mg/kg in children aged 6 months to 2 years (Eficacia del Mivacurium administrado a dosis de 200 y 205 µg/kg en niños de 6 meses a dos años de edad)
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Scientific title
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Acronym
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N/A
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Serial number at source
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HIM 97/011
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Study hypothesis
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Patients undergoing an elective surgery of a planned duration not longer than 1 hour while requiring tracheal intubation during the procedure.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Mexico
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Disease/condition/study domain
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Anesthesia in children 6-24 months
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Participants - inclusion criteria
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1. Children aged 6 to 24 months
2. Low surgical risk (American Society of Anesthesiologists [ASA] grade I)
3. Suffering any ophthalmic, oto-rhynologic, plastic or orthopaedic disease
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2000
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Anticipated end date
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01/01/2001
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Status of trial
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Completed
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Patient information material
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Target number of participants
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24
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Interventions
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Patients randomly received an intravenous (iv) bolus dose of mivacurium 200 or 250 mg/kg. Isoflurane was administered to maintain anesthetic level during the surgical procedure. The times to onset of action and to spontaneous recovery of neuromuscular function were compared between groups. The area under-the-curve of the Heart Rate (HR), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were also compared between groups.
Ancillary analyses: In every group, the HR and SBP and DBP data obtained 5 min after mivacurium was administered were compared to their respective baseline values. In order to evaluate the effect of age and weight into onset and recovery times (data from all children), a single linear regression analysis (y = mx + b) was performed between each of the onset and recovery times as the dependent or explained variable and age or weight as the independent variable.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. Fund to Encourage Research of the Mexican Institute of Social Security (Fondo de Fomento a la Investigacion of the Instituto Mexicano del Seguro Social) (Mexico) (grant ref: FP0038/988)
2. Secretariat of Public Education - National Council of Science and Technology (Secretraria de Educacion Publica - Consejo Nacional de Ciencia y Tecnologia [SEP-CONACyT]) (Mexico) (grant ref: 30591-M)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11722796
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Contact name
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Dr
AA
Nava-Ocampo
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Address
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Unit of Medical Research in Pharmacology
Centro Médico Nacional
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City/town
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Mexico City
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Zip/Postcode
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03020
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Country
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Mexico
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Email
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navaocampo_aa@yahoo.com
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Sponsor
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Federico Gomez Infant Hospital of Mexico (Hospital Infantil de Mexico Federico Gomez) (Mexico)
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Address
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Subdireccion de Investigacion
Dr. Marquez 162
Colonia Doctores
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City/town
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Mexico DF
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Zip/Postcode
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CP06720
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Country
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Mexico
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Date applied
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03/10/2001
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Last edited
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24/09/2007
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Date ISRCTN assigned
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03/10/2001
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