NCT02303223

Brief Summary

The principle objective of this study is to evaluate pharmacokinetics of propofol after single iv bolus dose in 12 Indian children and to develop a simple pharmacokinetic model of propofol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

October 26, 2014

Last Update Submit

January 28, 2015

Conditions

Propofol Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Plasma Propofol concentration

    0, 2, 4, 6, 10, 20, 30, 60, 90, 120, 240 and 480 minutes post loading dose of Propofol

Study Arms (1)

Propofol

OTHER

Single intravenous bolus dose of Propofol 2.5mg/kg for induction of anesthesia

Drug: Propofol

Interventions

PropofolDRUG
Propofol

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5-12 years and ASA (American Society of Anesthesiologists) grade I, planned for elective surgery under general anesthesia

You may not qualify if:

  • Allergic history to one of the constituents of propofol
  • Any evidence of cardiovascular, respiratory,metabolic ,renal ,hematologic,hepatic or central nervous system disease
  • Previous adverse anesthetic events
  • Potential airway management problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

Related Publications (3)

  • Kataria BK, Ved SA, Nicodemus HF, Hoy GR, Lea D, Dubois MY, Mandema JW, Shafer SL. The pharmacokinetics of propofol in children using three different data analysis approaches. Anesthesiology. 1994 Jan;80(1):104-22. doi: 10.1097/00000542-199401000-00018.

    PMID: 8291699BACKGROUND

  • Pavan I, Buglione E, Massiccio M, Gregoretti C, Burbi L, Berardino M. Monitoring propofol serum levels by rapid and sensitive reversed-phase high-performance liquid chromatography during prolonged sedation in ICU patients. J Chromatogr Sci. 1992 May;30(5):164-6. doi: 10.1093/chromsci/30.5.164.

    PMID: 1322421BACKGROUND

  • Marsh B, White M, Morton N, Kenny GN. Pharmacokinetic model driven infusion of propofol in children. Br J Anaesth. 1991 Jul;67(1):41-8. doi: 10.1093/bja/67.1.41.

    PMID: 1859758BACKGROUND

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Goverdhan D Puri, MD

    Post Graduate Institute of Medical Education and Research, Chandigarh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate resident

Study Record Dates

First Submitted

October 26, 2014

First Posted

November 27, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

IN(1)