NCT02544854

Brief Summary

By measuring plasmatic concentration of propofol at different intervals during surgery of children aged 1 to 12 years old and measuring Bispectral Index (BIS) as a surrogate for cerebral activity, the investigators aim to create a pharmacokinetic/pharmacodynamic model of propofol for children.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

September 6, 2015

Last Update Submit

October 10, 2016

Conditions

Anesthesia

Keywords

Pharmacokinetics, pharmacodynamics, propofol, pediatrics

Outcome Measures

Primary Outcomes (1)

  • Propofol plasmatic levels

    Measured by high pressure liquid chromatography

    From start of infusion: 5 min, 15 min, 45 min; from bolus 0 min, 1 min, 3 min, 5 min, 10 min; after infusion 30 min, 60 min, 120 min, 360 min

Secondary Outcomes (5)

  • Hemodynamics

    Entering operating room up to end of anesthesia

  • Propofol total dose

    Start of propofol infusion until it ends

  • Sevoflurane total dose

    Start of inhalational induction to zero end tidal concentration

  • Pulse oximetry

    Entering operating room up to end of anesthesia

  • BIS

    Entering operating room up to end of anesthesia

Study Arms (3)

Ages 1 year - 3 years 11 months

EXPERIMENTAL

Propofol infusion, measuring of plasmatic levels of propofol through venous sampling

Drug: Propofol

Ages 4 years - 8 years 11 months

EXPERIMENTAL

Propofol infusion, measuring of plasmatic levels of propofol through venous sampling

Drug: Propofol

Ages 9 years - 11 years 11 months

EXPERIMENTAL

Propofol infusion, measuring of plasmatic levels of propofol through venous sampling

Drug: Propofol

Interventions

PropofolDRUG

Propofol infusion will be started after inhalational induction by manual infusion by the following scheme: 1. First 15 minutes: 15 mg/kg/min 2. 16 to 30 minutes: 13 mg/kg/min 3. 31 to 60 minutes: 11 mg/kg/min 4. 61 to 120 minutes: 10 mg/kg/min Dose will be titrated to maintain BIS between 40 - 50. Venous sampling for plasmatic levels of propofol measuring will be made at the following moments: 1. 5, 15 and 25 minutes of starting infusion, 2. 1, 3, 5, 7, 9 and 12 minutes of bolus and, 3. 5, 25, 60 and 120 minutes of infusion ended.

Also known as: Diprivan
Ages 1 year - 3 years 11 monthsAges 4 years - 8 years 11 monthsAges 9 years - 11 years 11 months

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 1 year through 11 years 11 months and 29 days old.
  • American Society of Anesthesiology (ASA) score 1 or 2.
  • Elective surgery of more than 1 hour of expected duration.
  • Written informed consent signed by parents or legal guardians.
  • Oral and written consent in children aged over 7 years old.

You may not qualify if:

  • Known allergies to study drugs.
  • Use of any medication acting on central nervous system in the last 24 hours previous to surgery.
  • Chronic cardiac, renal, hepatic or neurologic disease that determines abnormal function.
  • Difficult airway (predicted or known).
  • Use of neuraxial anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division de Anestesia - Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

Related Publications (8)

  • Gibert S, Sabourdin N, Louvet N, Moutard ML, Piat V, Guye ML, Rigouzzo A, Constant I. Epileptogenic effect of sevoflurane: determination of the minimal alveolar concentration of sevoflurane associated with major epileptoid signs in children. Anesthesiology. 2012 Dec;117(6):1253-61. doi: 10.1097/ALN.0b013e318273e272.

    PMID: 23103557BACKGROUND

  • Kearns GL, Reed MD. Clinical pharmacokinetics in infants and children. A reappraisal. Clin Pharmacokinet. 1989;17 Suppl 1:29-67. doi: 10.2165/00003088-198900171-00005.

    PMID: 2692939BACKGROUND

  • Fuentes R, Cortinez I, Ibacache M, Concha M, Munoz H. Propofol concentration to induce general anesthesia in children aged 3-11 years with the Kataria effect-site model. Paediatr Anaesth. 2015 Jun;25(6):554-9. doi: 10.1111/pan.12657. Epub 2015 Apr 16.

    PMID: 25880448BACKGROUND

  • Rigouzzo A, Servin F, Constant I. Pharmacokinetic-pharmacodynamic modeling of propofol in children. Anesthesiology. 2010 Aug;113(2):343-52. doi: 10.1097/ALN.0b013e3181e4f4ca.

    PMID: 20613468BACKGROUND

  • Coppens MJ, Eleveld DJ, Proost JH, Marks LA, Van Bocxlaer JF, Vereecke H, Absalom AR, Struys MM. An evaluation of using population pharmacokinetic models to estimate pharmacodynamic parameters for propofol and bispectral index in children. Anesthesiology. 2011 Jul;115(1):83-93. doi: 10.1097/ALN.0b013e31821a8d80.

    PMID: 21555936BACKGROUND

  • Panchatsharam S, Callaghan M, Day R, Sury MR. Measured versus predicted blood propofol concentrations in children during scoliosis surgery. Anesth Analg. 2014 Nov;119(5):1150-7. doi: 10.1213/ANE.0000000000000413.

    PMID: 25225889BACKGROUND

  • Howie SR. Blood sample volumes in child health research: review of safe limits. Bull World Health Organ. 2011 Jan 1;89(1):46-53. doi: 10.2471/BLT.10.080010. Epub 2010 Sep 10.

    PMID: 21346890BACKGROUND

  • Fuentes R, Cortinez LI, Contreras V, Ibacache M, Anderson BJ. Propofol pharmacokinetic and pharmacodynamic profile and its electroencephalographic interaction with remifentanil in children. Paediatr Anaesth. 2018 Dec;28(12):1078-1086. doi: 10.1111/pan.13486. Epub 2018 Oct 11.

    PMID: 30307663DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ricardo Fuentes, MD

    Professor

    PRINCIPAL INVESTIGATOR

  • Rose M Heider, MD

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Fuentes, MD

CONTACT

56-9-77648344rfuente@med.puc.cl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2015

First Posted

September 9, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

CL(1)