14 Clinical Trials for Various Conditions
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.
Patients who are in the intensive care unit after surgery and require mechanical breathing support (intubation and ventilation) usually require sedation to avoid agitation and excessive stress responses. Short-acting sedatives such as midazolam and propofol are the drugs typically used for this. Propofol provides for fast sedation and fast recovery from sedation. Midazolam is slower to sedation and slower for recovery, but may provide some advantages over propofol, such as a lower incidence of hypotension (low blood pressure). This study will look at propofol compared to a product with fast sedation and recovery like that of propofol but with less of a chance for hypotension like with midazolam. Patients will be treated with the product for up to 8 hours and then will be monitored for 8 hours following treatment.
Nausea after surgery may negatively influence patient satisfaction, may delay discharge, and cause unexpected hospital admissions. The trend toward ambulatory surgery has increased the focus on postoperative nausea, but published evidence is not based on standardized criteria for assessment. Therefore, the results for postoperative nausea are very diverse, especially reports on nausea incidence after regional anesthesia, i.e. spinal anesthesia. When peripheral nerve blocks have been applied for postoperative pain control, they significantly reduce postoperative pain, opioid consumption and side effects; patients receiving general anesthesia (GA) and nerve blocks are thought likely to have less nausea than patients receiving GA alone. This study is a pilot study looking at the incidence and intensity of nausea after orthopedic surgery under nerve blocks in foot and ankle (FA) patients and under nerve blocks with either sedation or GA in total shoulder arthroplasty (TSA) patients. The results of this study will help power a future randomized controlled trial, comparing the incidence and intensity of nausea in FA patients receiving GA through laryngeal mask airway (LMA) versus spinal anesthesia.
SATIRE is a prospective, randomized control trial assessing two methods of administration of intravenous sedation and narcotics in surgical patients requiring mechanical ventilation. Many hospitals use a continuous infusion method of administering these medications. The investigators hypothesize that intermittent, bolus/sliding-scale based administration will lead to less medication being given and subsequently decrease the amount of time on mechanical ventilation without compromising patient comfort or level of sedation. Patients are randomized into a control arm (continuous infusion) and a trial arm (sliding scale hourly bolus) using versed for sedation and fentanyl for pain medication. Inclusion criteria are surgical patients requiring mechanical ventilation, including trauma patients, post operative patients, etc. Primary end point is total time of mechanical ventilation in each arm. Secondary end points are amount of medication given, time in ICU, time to discharge. Mortality and adverse events in both arms are recorded and reported to the Institutional Review Board for monitoring.
The main goal of this study is to allow the anesthesiologist to make a more informed decision about the anesthetic requirement of a person prior to starting anesthesia. The preliminary data collected in this study will support a larger investigation aimed at gaining a better understanding of anesthetic susceptibility in general and in the elderly population which appears to be at greater risk for Postoperative Cognitive Dysfunction (POCD) POCD is a short-term decline in cognitive function (especially in memory and executive functions) that may last from a few days to a few weeks after surgery. In rare cases, this disorder may persist for several months after major surgery. POCD is distinct from emergence delirium. It occurs most commonly in older patients and those with pre-existing cognitive impairment. POCD is common in adult patients of all ages at hospital discharge after major non-cardiac surgery, but only the elderly (aged 60 years or older) are at significant risk for long-term cognitive problems. The body's inflammatory response to surgery likely plays an important role, at least in elderly patients. Investigators also postulate that a relative 'anesthetic overdose' may be a significant risk factor. Hence, being able to make a better judgment on the dose needed for an individual is extremely important.
It is difficult to assess pain and agitation in the NICU population because for a multitude of reasons including the pre-verbal nature of the patient population, the atypical pain response of premature infants, and the use of muscle relaxing medications that exclude motor response in pain assessments. Current assessment tools are based on physical exam and vital signs. The investigators propose to study the role of EEG and palmar conductance (PD) as additional tools in the assessment of pain and agitation
Investigators will assess the incidence and duration of postoperative delirium in patients ≥60 years old undergoing coronary artery bypass grafting (CABG), with/without valve surgery (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia. Patients will receive either intravenous (IV) dexmedetomidine and IV acetaminophen or standard postoperative management using IV propofol with morphine or hydromorphone. The Confusion Assessment Method (CAM) will be used to assess delirium in these patients. Investigators also seek to compare postoperative (48 hours) analgesic requirements in patients with or without IV acetaminophen. Investigators will finally assess postoperative cognition in post-surgical patients up to one year post-discharge using a cognitive assessment scale.
Dexmedetomidine (Dex), a selective α2-adrenergic receptor agonist, is the most used sedative for procedural sedation in children and in pediatric Intensive Care Unit (PICU) because it is associated with less respiratory depression and also less neurotoxicity; rather Dex appears neuroprotective. Unfortunately, Dex is associated with very long emergence times and may cause bradycardia and hypotension. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. With this Dex sedation protocol, these pediatric patients usually take an average of 45 minutes (30-60 minutes) to wake and become alert and up to 2 hours to be discharged. Without reversal agents, emergence times from Dex sedation are slow. The prolonged recovery after Dex sedation for non-surgical procedures negatively affects throughput, thus increasing the cost of care. Patient safety and satisfaction suffer as a result. The children wake feeling tired and sluggish. The children don't feel back to normal for an extended period of time, which is not surprising given that the half-life for Dex metabolism in 2-3 hours in humans. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. In humans, it has been found that caffeine at 7.5 mg/kg (15 mg caffeine citrate equivalent to 7.5 mg caffeine base) sped emergence from isoflurane anesthesia with minimal hemodynamic effects in healthy human volunteers. The goal of this clinical trial is to determine whether caffeine will facilitate the recovery of Dex sedation after a Magnetic Resonance Imaging (MRI) procedure by measuring the time from the end of Dex infusion to the time meeting the discharge criteria.
Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal.
Effect of nicotine patch as an adjutant for acute pain after surgery.
The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoracic surgery after discharge from PACU or ICU.
The study comprises of a series of pupillary measurements using infrared pupillometry in patients undergoing arthroscopic knee surgery of any type. Infrared pupillometry will be used to assess whether a painful stimulus results in pupillary reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is. This may help to predict the amount of discomfort a patient will be experiencing after emergence from general anesthesia. In addition to measuring the pupillary reflex dilation, we will also measure oscillations of pupil size before and after indiction of anesthesia, as well as during recovery. These spontaneously occuring oscillations in pupil size, also called hippus, appear to be sensitive to anesthetics and opioids. However, the effect of these drugs on hippus has not been systematically addressed. The aim of the study is 1. to identify whether regional anesthesia techniques such as femoral and sciatic nerve blocks will block the PRD. This would allow assessment of block success in the anesthetized patient. 2. to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized patient during and at the end of surgery with early postoperative pain scores and subsequent analgesia requirements. Such correlation would allow to predict the amount of postoperative pain before the patients emerge from general anesthesia.
Following an obtained written consent, a child presenting for ear tube surgery will be randomized into one of three groups for receiving a premedication. One group will be the current therapy with midazolam, another group will be another drug dexmedetomidine, and the third group will be a combination of midazolam plus dexmedetomidine. Observers in the study (the investigators fellow and advance practice nurse) will not know which group each patient belongs, and will then make three separate assessments: preoperative sedation, mask acceptance, and postoperative delirium. Mask acceptance: Induction of anesthesia, or the beginning of the process for the patient to fall asleep and lose consciousness, involves placing a mask over there face, specifically the nose and mouth. The mask is connected to their anesthesia machine via tubing, or a circuit, through which their anesthetic gases flow. Some children fight the mask as it can be seen as new and frightening. Other children, sometimes depending on how sedated they are after receiving a premedication, do not fear the mask on their face and do not resist induction. How well or easily this happens can be described as "mask acceptance." Postoperative delirium can be seen in patients of any age or after any surgery and can be better defined as a mental disturbance during the recovery from general anesthesia consisting of hallucinations, delusions, and confusion manifested by moaning, restlessness, involuntary physical activity, and thrashing about in bed. It has been considered a common postanesthetic problem in children and adults since 1960. Each patient will then have a set of numbers for each scale; following conclusion of the study the investigators will be able see which drug each patient received and statistical analysis can be completed. The investigators goal is to see if there is any difference in any of the scales depending which medication was administered. The scales to be utilized include the pre-operative sedation scale, the mask acceptance scale, and the pediatric emergence delirium scale.
The purpose of this study is to determine whether an intravenous infusion of dexmedetomidine administered to surgical patients intra-operatively will improve the characteristics of sleep post-operatively.