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 |
| Secondary identifying numbers | HIM 97/011 |
- 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
Scientific
Unit of Medical Research in Pharmacology
Centro Médico Nacional
Mexico City
03020
Mexico
| navaocampo_aa@yahoo.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mivacurium |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2000 |
| Completion date | 01/01/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 24 Months |
| Sex | Both |
| Target number of participants | 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
03020
Mexico
Sponsor information
Federico Gomez Infant Hospital of Mexico (Hospital Infantil de Mexico Federico Gomez) (Mexico)
Hospital/treatment centre
Hospital/treatment centre
Subdireccion de Investigacion
Dr. Marquez 162
Colonia Doctores
Mexico DF
CP06720
Mexico
"ROR" |
https://ror.org/00nzavp26 |
|---|
Funders
Funder type
Research organisation
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)
No information available
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
