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Propofol Pharmacokinetics in Children After Single Bolus Dose

NCT ID: NCT02303223

Last Updated: 2015-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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).

Conditions

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Propofol Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Propofol

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

Group Type OTHER

Propofol

Intervention Type DRUG

Interventions

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Propofol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Naveen Naik

Post graduate resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Goverdhan D Puri, MD

Role: STUDY_DIRECTOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

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Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 8291699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1322421 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1859758 (View on PubMed)

Other Identifiers

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NK/MD/1008/13592-93

Identifier Type: -

Identifier Source: org_study_id