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)

ISRCTN	ISRCTN07742712
DOI	https://doi.org/10.1186/ISRCTN07742712
Protocol serial number	HIM 97/011
Sponsor	Federico Gomez Infant Hospital of Mexico (Hospital Infantil de Mexico Federico Gomez) (Mexico)
Funders	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), 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)

Submission date: 03/10/2001
Registration date: 03/10/2001
Last edited: 24/09/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr AA Nava-Ocampo
Scientific

Unit of Medical Research in Pharmacology
Centro Médico Nacional
Mexico City
03020
Mexico

Email	navaocampo_aa@yahoo.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Patients undergoing an elective surgery of a planned duration not longer than 1 hour while requiring tracheal intubation during the procedure.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Mivacurium
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2001

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	24 Months
Sex	All
Target sample size at registration	24
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2000
Date of final enrolment	01/01/2001

Locations

Countries of recruitment

Mexico

Study participating centre

Unit of Medical Research in Pharmacology

Mexico City
03020
Mexico

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/01/2001		Yes	No