Contact information
Type
Scientific
Primary contact
Dr AA Nava-Ocampo
ORCID ID
Contact details
Unit of Medical Research in Pharmacology
Centro Médico Nacional
Mexico City
03020
Mexico
navaocampo_aa@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HIM 97/011
Study information
Scientific title
Acronym
Study hypothesis
Patients undergoing an elective surgery of a planned duration not longer than 1 hour while requiring tracheal intubation during the procedure.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Anesthesia in children 6-24 months
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Mivacurium
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
01/01/2001
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
24
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2000
Recruitment end date
01/01/2001
Locations
Countries of recruitment
Mexico
Trial participating centre
Unit of Medical Research in Pharmacology
Mexico City
03020
Mexico
Funders
Funder type
Research organisation
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11722796
Publication citations
-
Results
Nava-Ocampo AA, Aguirre-Garay FT, Velázquez-Armenta EY, Moyao-García D, Effect of mivacurium 200 and 250 &mgr;g/kg in infants during isoflurane anesthesia: a randomized controlled trial [ISRCTN07742712]., BMC Anesthesiol, 2001, 1, 1, 1.