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Sedation clinical trials

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NCT ID: NCT00832013 Completed - Sedation Clinical Trials

Safe Administration of Propofol for Sedation in Children

Start date: June 2008
Phase: N/A
Study type: Interventional

Advances in health care require that more children are given sedation to allow doctors to perform investigations or minor procedures. Sedation drugs have traditionally been given orally (swallowed) by children. However, oral sedation drugs have unpredictable characteristics, such as duration of sedation, which may result in difficulties performing the planned procedure. Anesthetic drugs are now invariably used for sedation in children. These are given through an IV (skinny plastic tube inserted in to a vein). Propofol (white liquid) is the anesthetic drug most commonly used for sedation at BC Children's Hospital for sedation. Propofol has several advantages, including an accurately controllable depth of sedation (how deeply asleep), minimal effect on the heart and circulation and control of reflexes (e,g coughing) during the procedure. Propofol also promotes rapid recovery with less sickness and an earlier return to normal functioning following the procedure. While propofol has many advantages it can cause respiratory depression (reduced breathing rate). This reduction in breathing is more common if propofol is given quickly. When your child is given propofol for their proposed procedure this is performed by a pediatric anesthesiologist who is skilled in supporting breathing should this be required. If your child does not participate in this study they will still receive propofol administered by the anesthesiologist as this is our usual practice. It would be routine to administer the propofol rapidly and then support breathing for a few minutes. This is very safe in the hands of an expert anesthesiologist but can be sometimes more risky in other settings where extensive monitoring and anesthesiologists are not available. This is the setting that propofol is used in many institutions. Our goal is to determine how quickly propofol can be given without reducing breathing to the point that help with breathing is required.

NCT ID: NCT00789412 Completed - Pain Clinical Trials

Surgical Stress Index as a Tool for Monitoring Analgesia and/or Sedation in Critically Ill Patients

Start date: August 2008
Phase: N/A
Study type: Observational

The hypothesis of the study is: Does the Surgical Stress Index (SSI) correlate with the Behavioral Pain Scale (BPS), the Ramsay Sedation Scale (RSS)and/or the Behavioral Pain Scale(BPV) and can therefore be used to monitor the quality of analgosedation in noncommunicative intensive care unit patients?

NCT ID: NCT00747721 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU

DEX PK
Start date: September 2008
Phase: Phase 1
Study type: Interventional

The study will examine dexmedetomidine levels in the blood of critically ill intensive care patients to understand how it is broken down by the body.

NCT ID: NCT00730054 Completed - Acute Pain Clinical Trials

Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers

Remiclon
Start date: February 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior.

NCT ID: NCT00697788 Completed - Burns Clinical Trials

Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Start date: January 2006
Phase: Phase 2
Study type: Interventional

Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.

NCT ID: NCT00618397 Terminated - Sedation Clinical Trials

Pharmacokinetics of Low Dose Ketamine Infusion

Start date: June 2006
Phase: Phase 1
Study type: Interventional

Opioids, such as fentanyl, are commonly used in PICU patients to provide comfort and pain control. Opioid tolerance, the need to increase the dose of medication to achieve the same effect,is seen in PICU children who require opioid infusions. Animals and human studies have shown that activation of the N-methyl-D-aspartate (NMDA) receptor is involved in the development of opioid tolerance and that deactivation of this receptor can slow the development of tolerance. Ketamine, an NMDA receptor antagonists, turns off the NMDA receptor. Ketamine is used to provide sedation and anesthesia in children. Its use in inhibiting the development of opioid tolerance has not been tested in children. We aim to determine ketamine's effectiveness in the treatment of tolerance in PICU patients who require fentanyl infusions to treat pain and discomfort . Some physicians have reported using ketamine doses of 0.04mg/kg/hr to 0.5mg/kg/hr to inhibit opioid tolerance. We propose to study the sedative effect, and the metabolism of, three doses of ketamine, 0.1mg/kg/hr, 0.3mg/kg/hr, and 0.5mg/kg/hr. Patients admitted to the PICU, requiring a breathing machine and fentanyl infusion for discomfort or pain control will be enrolled. Patients' age three to eighteen years will be enrolled. Patients will receive a ketamine infusion once their COMFORT scores indicate an adequate sedation/comfort level on their current sedation regimen. The COMFORT score is a validated scale that measures distress in PICU patients. The COMFORT score will be continued for the twelve hours the patient receives the ketamine to test whether the ketamine adds to the level of sedation. Blood samples during and following the ketamine infusion will be taken to determine how ketamine and norketamine (one of ketamine's metabolites) are used in the body. To determine the effect of ketamine on tolerance it must be a ketamine dose that does not cause additional sedation. The goal of this study is to define a non-sedating dose of ketamine and define how it is used by the body. A non-sedating ketamine dose could be added to current sedation regimens allowing us to monitor the development of tolerance without the confusion of added sedation. The data obtained in this study will be used to design a study to further investigate the effect of ketamine on opioid tolerance.

NCT ID: NCT00526760 Completed - Sedation Clinical Trials

Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects

Start date: October 2007
Phase: Phase 3
Study type: Interventional

Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.

NCT ID: NCT00421720 Terminated - Analgesia Clinical Trials

A Study Comparing Two Analgesia/Sedation Regimens, Remifentanil/Propofol Versus Sufentanil/Propofol In Mechanically Ventilated Intensive Care Patients Requiring Analgesia And Sedation.

Start date: January 2007
Phase: Phase 4
Study type: Interventional

This prospective, randomized, multicenter, open-label study will compare two analgesia-based regimens for sedation (remifentanil/propofol vs. sufentanil/propofol) in medium to long-term ventilated intensive care patients in terms of efficacy, safety and resource utilization. The special characteristics of intensive care patients (organ insufficiencies etc.) regularly cause an accumulation of the analgesics, sedatives and adjuvants used. Clinically, this complicates the calculation of weaning and extubation times, often making mechanical ventilation necessary for longer periods than desired and also extending the stay of patients in the intensive care unit. Reducing weaning times and the duration of intensive care treatment by optimizing analgesia/sedation could furthermore lead to a reduction in typical complications such as ventilator-associated pneumonia or delirium. The demands on an ideal analgesic are analgesic efficacy without severe cardiopulmonary depression and rapid onset of effect and in particular a short dura-tion of effect and absence of accumulation or development of active metabolites. Remifentanil is an ultra-short acting µ-agonist which is, due to its molecular structure, metabolized organ-independently by unspecific blood and tissue esterases with the substance being degraded within only a few minutes and the resulting metabolites being virtually ineffective at the µ-receptor. Sufentanil, on the other hand, is mainly metabolized by the cytochrome P-450-3A4 enzyme in the liver and small intestine. To date, only one study with a small sample size is available on the comparison of the effectiveness and safety of remifentanil and sufentanil when used for long-term analgesia/sedation.

NCT ID: NCT00409344 Terminated - Sedation Clinical Trials

Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms

Start date: January 2007
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to test the hypothesis that time on the ventilator and ICU length of stay will be shorter in TAA patients given postoperative sedation with dexmedetomidine compared to those given standard sedation. Secondary endpoints are: requirement for sedatives vasoactive drugs incidence of postoperative delirium and cost analysis.

NCT ID: NCT00401206 Completed - COPD Clinical Trials

Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study

Start date: November 2006
Phase: N/A
Study type: Interventional

To determine safety and effectiveness of dexmedetomidine when administered for conscious sedation during flexible bronchoscopy (FB) in patients with Chronic Obstructive pulmonary Disease (COPD).