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Sedation clinical trials

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NCT ID: NCT01378988 Completed - Pain Clinical Trials

Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months

Start date: June 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through <24 months, administered as an intravenous loading dose followed by continuous infusion for a minimum of 6 hours and up to 24 hours in an intensive care setting.

NCT ID: NCT01269307 Completed - Sedation Clinical Trials

Combination Ketamine and Propofol vs Propofol for Emergency Department Sedation: A Prospective Randomized Trial

Start date: June 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if procedural sedation utilizing a 1:1 mixture of propofol and ketamine is equivalent in complications, patient and physician satisfaction, post-procedure pain level, and procedural outcome to propofol sedation alone.

NCT ID: NCT01255904 Completed - Sedation Clinical Trials

A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams

Start date: August 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).

NCT ID: NCT01212419 Completed - Surgery Clinical Trials

SWC on aEEG in Post-surgical Neonates on Morphine and Midazolam

Start date: March 2009
Phase: N/A
Study type: Observational

Objectives: Sleep characteristics have been used for prediction of neuro-developmental outcome. The aim of our study was to evaluate the influence of morphine and midazolam on the development of SWC in newborns > 32 weeks' gestational age after major non-cardiac surgery. Study design: This prospective aEEG study included infants > 32+0 weeks' gestation admitted to the Neonatal Intensive Care Unit at The Royal Children's Hospital in Melbourne who were undergoing major non-cardiac surgery. The BrainZ Monitor (BRM2, Version 8.0, BrainZ Instruments, New Zealand) was applied post-operatively. The time of onset and quality of SWC and the maximum levels of morphine and midazolam as predictors of time to SWC were then assessed. Results: Forty-seven eligible infants were included. Emergence of SWC was observed at a mean of 13 hours post-surgery. The maximum dose of morphine or midazolam was not predictive of time to SWC. Conclusions: Despite high doses of continuous infusions of morphine and midazolam SWC was observed on aEEG in neonates > 32 weeks' gestational age soon after major non-cardiac surgery. The main type of aEEG background pattern was not affected by the maximum dose of either morphine or midazolam. Abnormalities in aEEG in post-surgical patients are not always drug related.

NCT ID: NCT01196754 Completed - Sedation Clinical Trials

Pharmacokinetic of Sevoflurane During a 48h Sedation in Intensive Care Unit With AnaConDa®

Anaconda
Start date: March 2008
Phase: N/A
Study type: Interventional

This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane.

NCT ID: NCT01159262 Completed - Sedation Clinical Trials

Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

Start date: July 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).

NCT ID: NCT01158820 Completed - Sedation Clinical Trials

Alternative Sedation During Bronchoscopy

DEX
Start date: June 2010
Phase: Phase 4
Study type: Interventional

This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.

NCT ID: NCT01145222 Completed - Sedation Clinical Trials

Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.

NCT ID: NCT01132794 Completed - Pain Clinical Trials

A Study to Assess the Analgesia and Sedation Using Intranasal Dexmedetomidine in Third Molar Surgery Under Local Anaesthesia

Start date: n/a
Phase: Phase 3
Study type: Interventional

Dental procedures such as wisdom tooth removal evoke very high levels of patients' anxiety and it is, therefore, common practice to provide concomitant pharmacologic sedation. Sedative agents can be administered by the oral, rectal, intra muscular and intravenous routes. The oldest, safest and most convenient route at present is the oral route. However, as Uygur-Bayramicli et al. mentioned that administering the drugs orally can result in problems like delayed effect. Intranasal administration is a straightforward procedure. It is simple and relatively painless. Although it may be objectionable, less patient cooperation is required than with oral administration, especially in which the child must swallow the medication. Many studies on dental sedation have been carried out by anesthesiologists but there is no ideal drug that can offer effects of both sedation and analgesia. Some drugs offer only one effect and others are not safe enough for clinical use. Midazolam, a benzodiazepine drug, is the traditional choice for sedation, but it has properties such as relatively slow onset and no analgesia. Propofol is an alkylphenol sedative and hypnotic agent with a rapid onset and offset. It has been used in patient controlled sedation before. But it has no analgesic properties. It can provide some antegrade amnesia, but it is not as reliable an amnestic as the benzodiazepine drugs. Because of these characteristics, propofol often is supplemented with narcotics and benzodiazepines. Although not irritant, it can cause pain during intravenous infusion. A new drug, an alpha agonist with its relatively high ratio of α2/α1-activity (1620:1 as compared with 220:1 for clonidine) of theα2 receptor is dexmedetomidine. This property may lead to more potent effects of both sedation and analgesia without unwanted cardiovascular effects fromα1 receptor activation. Most of the data evaluating the use of dexmedetomidine in the intensive care unit (ICU) were obtained in the immediate postoperative period, mainly in patients who underwent open-heart surgery. Currently, clinicians are awaiting studies in broader patient populations. In the studies that have been completed to date, sedation has been attained easily with maintenance of respiratory function. Patients are readily arousable. There is a minimal increase in blood pressure initially, followed by a slight decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of administration tend to decrease these circulatory side effects. So many clinical studies have shown that it can be well and safely used intravenously, intramuscularly and transdermally. Although not an officially technique, there are also reports of intranasal administration resulting in fairly predictable onset in both adults and children. The investigators propose that intranasal can help to improve postoperative pain relief with better sedation.

NCT ID: NCT01127438 Completed - Sedation Clinical Trials

A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations

Start date: April 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.