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Procedural Sedation clinical trials

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NCT ID: NCT02180737 Completed - Procedural Sedation Clinical Trials

Dexmedetomidine for Sedation During Radiological Interventional Procedures

Dexmed
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing interventional radiological procedures and measuring its different outcome variables.

NCT ID: NCT02145169 Completed - Procedural Sedation Clinical Trials

Inhaled Nitrous Oxide for the Prevention of Emergence Reaction During Ketamine Administration in Adults, a Pilot Study

Start date: October 2013
Phase: N/A
Study type: Interventional

To describe the safety and efficacy of nitrous oxide during ketamine administration for the prevention of emergence reaction during Emergency Department procedural sedation and analgesia in adults. Drugs such as fentanyl, midazolam, and propofol are widely used in emergency departments for procedural sedation and analgesia because they have a rapid onset and short duration of action. Unfortunately, all of these agents may cause respiratory depression, particularly when combined with other sedative agents, administered in large doses, or given to patients with underlying respiratory diseases. Nitrous oxide use during ketamine administration may be an ideal combination for the prevention of emergence reaction in adults sedated in the ED. Like ketamine, nitrous oxide has an excellent cardio-respiratory profile as well as some analgesic and anxiolytic qualities. The anxiety and pain surrounding procedural sedation is not limited to the procedure itself, but the elapsed time from the time the patient enters the ED to the time spent in preparation for the procedure can be significant and lead to increased anxiety, which may exacerbate emergence reactions in adults. Using nitrous oxide before ketamine administration may mitigate this. While midazolam has shown efficacy in reducing emergence reactions in adults sedated with ketamine, the investigators believe that inhaled nitrous oxide may be equivalent to midazolam, with a better cardio-respiratory profile.

NCT ID: NCT01402596 Withdrawn - Clinical trials for Traumatic Brain Injury

Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam

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

Thousands of children receive sedation for diagnostic and therapeutic interventions annually, and this number is expected to increase. Children are at higher risk for sedation-related complications than adults. In different scenarios, multiple drugs are used to achieve sedation, each one with particular adverse events that must be monitored and reported. Children that need CT scans for traumatic brain injuries often need sedation, without needing and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low incidence of adverse events; however, despite its worldwide use, it's being abandoned due to bitter taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam, on the other hand, produces high and fast concentrations on CSF with greater rates of success but probably with higher adverse events. There are no prospective studies with large series of patients using intranasal midazolam. The aim of this study is to determine if nasal midazolam is a safer approach and more effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT scans.

NCT ID: NCT01260662 Completed - Procedural Sedation Clinical Trials

Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation

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

This will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the Emergency Department (ED). Propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is also frequently used in the ED in children and sometimes in adults. It has been proposed that by combining the two agents, the negative side effects of respiratory depression and hypotension associated with propofol, and the negative effects of dysphoria and vomiting associated with ketamine, can be avoided. In the proposed study, patients seen in the ED who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. During the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.

NCT ID: NCT01227174 Not yet recruiting - Propofol Clinical Trials

Safety and Efficacy of Propofol Only Sedation in Oral and Maxillofacial Surgery

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

The purpose of this study is to determine if the use of propofol only to achieve procedural sedation for the removal of third molars is both safe and effective.

NCT ID: NCT01195103 Terminated - Orthopedic Surgery Clinical Trials

Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery

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

How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?

NCT ID: NCT00869440 Completed - Endoscopy Clinical Trials

Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy

Start date: March 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.

NCT ID: NCT00784498 Completed - Procedural Sedation Clinical Trials

Procedural Sedation Using Propofol Versus Midazolam/Ketamine in the Adult Emergency Department

Start date: November 2008
Phase: Phase 4
Study type: Interventional

The use of procedural sedation and analgesia (PSA) to accomplish painful procedures in the emergency department (ED) has become a standard of practice over the last decade. Substantial variance exists regarding usage of medication for PSA, and many anesthetic agents have been proposed for this use. To our knowledge no head to head study compared the clinical effectiveness, safety profile and amnestic properties of midazolam/ketamine vs. propofol regimens for PSA in the adult ED setting. This prospective randomized trail can will help to evaluate the effectiveness and safety profile of Midazolam/katamine regimen for ED PSA in adults and will contribute to the discussion regarding propofol roll in the ED.

NCT ID: NCT00464451 Withdrawn - Procedural Sedation Clinical Trials

Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The purpose of the study is: 1. To compare the efficacy of dexmedetomidine versus chloral hydrate as pediatric sedation agents for EEG studies. Efficacy will be determined by successful EEG study completion and by minimum degree of sedation induced patient agitation (SAS score). 2. To compare the safety and adverse event profile of dexmedetomidine versus chloral hydrate during sedation of pediatric patients for EEG studies. Comparison will be based on variance of vital signs (HR, MAP, RR, O2SAT, ETCO2) from baseline during sedation as well as the frequency of adverse events during and following sedation. 3. To compare quality of EEG recording obtained with dexmedetomidine or chloral hydrate and to those of non-sedated pediatric EEG studies. Quality will be determined by the degree of background beta-wave activity.

NCT ID: NCT00327392 Completed - Procedural Sedation Clinical Trials

A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.

Start date: May 2006
Phase: Phase 2/Phase 3
Study type: Interventional

Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.