Propofol Pharmacokinetics in Children After Single Bolus... | NCT02303223

Studies
Propofol Pharmacokinetics in Children After Single Bolus Dose

NCT02303223

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Completed

Last Update Posted

Jan 30, 2015Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Propofol Pharmacokinetics

Interventions

Propofol

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Jan 2015Actual

First Submitted Date

Oct 26, 2014

First Submission Date that Met QC Criteria

Nov 26, 2014

First Posted Date

Nov 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2015

Last Update Posted Date

Jan 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Naveen Naik, Post graduate resident, Post Graduate Institute of Medical Education and Research, ChandigarhPrincipal Investigator

Lead Sponsor

Post Graduate Institute of Medical Education and Research, ChandigarhOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propofol	Other	Single intravenous bolus dose of Propofol 2.5mg/kg for induction of anesthesia	Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug		Propofol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Goverdhan D Puri, MD	Post Graduate Institute of Medical Education and Research, Chandigarh	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Post Graduate Institute of Medical Education and Research		Chandigarh	Chandigarh	160012	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8291699	Background	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.
1322421	Background	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.

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic