Propofol Pharmacokinetics in Children After Single Bolus Dose

Not Applicable

Completed

• Conditions: Propofol Pharmacokinetics
• Interventions: Drug: Propofol

• Registration Number: NCT02303223
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-10-26
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Primary Completion: 2014-12
• Status Verified: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India