Condition category
Surgery
Date applied
03/10/2001
Date assigned
03/10/2001
Last edited
24/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Federico Gomez Infant Hospital of Mexico (Hospital Infantil de Mexico Federico Gomez) (Mexico)

Sponsor details

Subdireccion de Investigacion
Dr. Marquez 162
Colonia Doctores
Mexico DF
CP06720
Mexico

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes