Ketamine Pharmacokinetics in Children Having Heart Surgery

Status Completed

Clinical Trial Summary

What are the pharmacokinetics of ketamine in infants and children requiring ketamine for induction of anesthesia for cardiac surgery that requires CPB? Specific Aim 1: To determine the pharmacokinetic parameters of a single intravenous bolus dose of ketamine in infants and children undergoing cardiac surgery with and without CPB (cardio-pulmonary bypass).

Specific Aim 2: To describe the disposition of ketamine's primary active metabolite, norketamine,following a single intravenous bolus dose of ketamine in infants and children undergoing cardiac surgery with and without CPB.

Specific Aim 3: To determine the relationship between ketamine and norketamine pharmacokinetic parameters and age as well as CPB time.

Clinical Trial Description

The role of ketamine in pediatric anesthesia is well established. It is one of the most commonly used agents for conscious sedation in pediatrics. Its widespread use stems for its abrupt onset of action and brief duration of sedation. There is limited ketamine pharmacokinetic data in children and none to our knowledge in infants and young children who will be given an intravenous bolus dose before a surgical procedure that includes cardiopulmonary bypass.

Ketamine is marketed as a racemic mixture (50:50 mixture of S- and R-ketamine enantiomers).

Ketamine undergoes N-demethylation (CYP3B6, 2C9, and 3A4) to its primary active metabolite,norketamine, with minor inactive metabolites, dehydroxynorketamine, generated secondary to direct oxidation. Ketamine exhibits a high intrinsic clearance with hepatic clearance dependent on hepatic blood flow under normal circumstances. One inherent disadvantage associated with the use of cardiopulmonary bypass (CPB) is the potential for organ dysfunction post-operatively.

We propose an open-label controlled study describing the disposition of ketamine in 28 infants and children who will be undergoing cardiac surgery with (n=16) and without (n=12) CPB. We anticipate that cardiopulmonary bypass alters the pharmacokinetics of ketamine. ;

Study Design

Related Conditions & MeSH terms

C.Surgical Procedure; Cardiac

Clinical Trial Details

NCT number	NCT00598195
Study type	Interventional
Source	Arkansas Children's Hospital Research Institute
Contact
Status	Completed
Phase	N/A
Start date	June 2006
Completion date	December 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02908009` - A Case Control Study to Identify the Role of Epigenetic Regulation of Genes Responsible for Energy Metabolism and Mitochondrial Function in the Obesity Paradox in Cardiac Surgery
Completed	`NCT01998438` - Prospective Trial of Tranexamic Acid in Cardiac Surgery	Phase 4
Completed	`NCT01805466` - Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO)	N/A
Completed	`NCT02571920` - Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA)	N/A
Completed	`NCT02658006` - Evaluation of Monitoring TECHNOlogies in the PERI-OPerative Care of Cardiac Surgical Patients	N/A
Completed	`NCT02267538` - Dexmedetomidine and Delirium in Patients After Cardiac Surgery	Phase 4
Completed	`NCT02866825` - Studying Complement Inhibition in Complex Cardiac Surgery	Phase 2
Completed	`NCT02513862` - Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery	N/A
Completed	`NCT02560519` - Albumin in Cardiac Surgery	Phase 4
Recruiting	`NCT03884725` - Fibrinogen Concentrate In Children Cardiac Surgery 2	Phase 4
Recruiting	`NCT01879475` - Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery	N/A
Completed	`NCT02972684` - Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass	N/A
Recruiting	`NCT02560285` - High-risk Patients in Cardiac Surgery Procedures: HiriSCORE	N/A
Terminated	`NCT02793895` - Detection of Atrial Fibrillation After Cardiac Surgery	N/A
Active, not recruiting	`NCT03343418` - Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery	Phase 4
Recruiting	`NCT03469440` - Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery	N/A
Recruiting	`NCT03882593` - Blood Cell Adhesion to Arterial Filters During Cardiac Surgery
Withdrawn	`NCT02119806` - Decreasing the Incidence of Delirium After Cardiac Surgery	Phase 4
Completed	`NCT02831907` - Portal Flow Pulsatility as a Risk Factor for Acute Kidney Injury After Cardiac Surgery	N/A
Recruiting	`NCT02745951` - HELIox CardiOPlegia Trial During Cardiac surgERy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.