Propofol Pharmacokinetics in Children After Single Bolus Dose

January 28, 2015 updated by: Naveen Naik, Postgraduate Institute of Medical Education and Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PROPOFOL is the most suitable agent currently available for induction and maintenance of anesthesia. So far, the pharmacokinetics of propofol has not been studied in Indian children. We believe that this pharmacokinetic characterization of propofol will help in better management of these patients undergoing surgery under total intravenous anesthesia (TIVA) in our setup. 12 ASA (American Society of Anesthesiologists) grade I patients, 5 to 12 years old planned for elective surgery will be included. Premedication will be done with syrup midazolam 0.5mg/kg. After shifting the patient to the operation table, routine physiological monitoring will be commenced and two intravenous lines will be secured,one in the antecubital vein of one arm and the other vein on the dorsum of the contralateral hand. The antecubital venous access will be used for blood sampling. Anesthetic technique will consist of fentanyl bolus dose of 2ug/kg followed by propofol bolus dose of 2.5 mg/kg. No further propofol will be administered. After loss of consciousness , patients will be paralysed with atracurium (0.5mg/kg) and endotracheal intubation will be performed. Anesthesia will be maintained with isoflurane, oxygen (50%) and nitrous oxide (50%), and intermittent dosages of atracurium. A total of twelve samples will be collected from each patient at 0, 2, 4, 6, 10, 20, 30, 60, 90, 120, 240, and 480 min after administration of bolus dose of propofol.The samples will be analyzed using a modified High Performance Liquid Chromatography method described by Pavan et al. The pharmacokinetic parameters will be evaluated using three compartment model to develop a pharmacokinetic model by using the software WINNONLIN (Windows Non Linear Regression Program).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Post Graduate Institute of Medical Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:entered

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Propofol
Single intravenous bolus dose of Propofol 2.5mg/kg for induction of anesthesia
Drug: Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma Propofol concentration
Time Frame: 0, 2, 4, 6, 10, 20, 30, 60, 90, 120, 240 and 480 minutes post loading dose of Propofol
0, 2, 4, 6, 10, 20, 30, 60, 90, 120, 240 and 480 minutes post loading dose of Propofol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Study Director: Goverdhan D Puri, MD, Post Graduate Institute of Medical Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 26, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 28, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK/MD/1008/13592-93

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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