Clinical Trials

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6 studies in Department of Anesthesiology in Rochester, MN.

  1. Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve

    Rochester, Minn. View Summary

    Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Postoperative Delirium or PD and Postoperative Cognitive Dysfunction or POCD are syndromes of central nervous system dysfunction that significantly complicate the recovery of a proportion of elderly patients following surgery. Delirium is typically a transient syndrome characterized by a de-novo appearance of several pathognomonic behaviors, including disorientation, decreased attention span, sensory misperceptions, a waxing-and-waning type of confusion, and disorganized thinking. PD typically occurs on postoperative days 1 to 3 and is associated with prolonged hospital stays, increased risks for morbidity and mortality and significant health care expenditures. The neuroendocrine stress response to surgery, including the immediate postoperative period, remains an important potential etiologic factor. In particular, our data suggests that stress in the immediate postoperative period is poorly controlled by all anesthetic techniques and the normal diurnal variation in cortisol is suppressed in subjects who develop POCD. Dexmedetomidine is a highly selective alpha 2A agonist currently approved for sedation in the ICU. Dexmedetomidine produces analgesia, sympatholysis, and a light sedation characterized by easy arousal. Its action converges on the endogenous substrates for natural sleep to produce their sedative action, an effect that could prove beneficial to elderly postoperative patients. We hypothesize that treatment with dexmedetomidine will diminish both PD and POCD. The essential proposition is that modulation of perioperative stress can ameliorate perioperative delirium and cognitive dysfunction. Based on both the concept of cognitive reserve as well as clinical experience, there is concern that patients with preoperative cognitive impairment are particularly vulnerable to POCD. In general, such patients have been excluded from previous studies. This study is unique in that we will assess all participants for mild cognitive impairment prior to surgery. Assessment of the impact of preexisting cognitive impairment is a secondary aim. A broad goal of this interdisciplinary project is to evaluate POCD, which is primarily an anesthesia concept, in the more general context of dementing illness as explored by geriatric psychiatry.

    NCT ID:

    NCT00561678

    Who can I contact for additional information about this study?

    Rochester: Chrsitopher Jankowski, MD 507-894-9695
                        


  2. Randomized Non-inferiority Trial of Continuous Thoracic Epidural Analgesia Versus Single Intercostal Nerve Block After Thoracotomy

    Rochester, Minn. View Summary

    Randomized Non-inferiority Trial of Continuous Thoracic Epidural Analgesia Versus Single Intercostal Nerve Block After Thoracotomy

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    In this study we will study to see if a single set of unilateral intercostal nerve blocks provides pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. Although the anesthesiologists involved in providing care for patients having thoracotomy incisions at SMH are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intraoperatively can provide comparable pain relief.

    NCT ID:

    NCT02178553

    IRB Number:

    14-002940

    Who can I contact for additional information about this study?

    Rochester: James D Hannon, MD 507-255-3298
                        Melissa A Passe, RRT 507-255-0965


  3. Local Assessment of Ventilatory Management During General Anesthesia for Surgery - a Prospective Observational Multi-center Cohort Study

    Rochester, Minn. View Summary

    Local Assessment of Ventilatory Management During General Anesthesia for Surgery - a Prospective Observational Multi-center Cohort Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Research questions - What MV-settings are used during general anesthesia for surgery? - Do MV-settings vary in and/or between centers? - Do MV-settings vary internationally? - Are MV-settings associated with incidence of intra-operative pulmonary complications? - Are MV-settings associated with incidence of post-operative pulmonary complications?

    NCT ID:

    NCT01601223

    Who can I contact for additional information about this study?

    Rochester: Juraj Sprung, MD
                        Shonie Buenvenida


  4. Equivalency Study of the CORA(R) and TEG(R) 5000 Systems

    Rochester, Minn. View Summary

    Equivalency Study of the CORA(R) and TEG(R) 5000 Systems

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The study protocol specifies testing using multiple reagents which are similar for both the CORA and TEG systems. Tests are run on blood samples taken from patients undergoing cardiovascular surgery and cardiology procedures, at two times throughout the procedure. The tests may be performed at three different pairs of times: Pre-Operation and Post-Protamine, or During Operation (Post-Heparin) and ICU, or Pre-Operation and ICU. Patients are selected at random for determination of which pair of times will be used, as long as the number of patients for each of the three groups is approximately the same. Following the protocol defined in CLSI Standard EP09-A2, equivalence between the two systems will be demonstrated if the conclusions from the Standard Section 7, Interpreting Results and Comparing to Internal Performance Criteria, are found to be acceptable. The study protocol also specifies the testing of blood samples from normal, health volunteer subjects for the purpose of determining CORA System Reference Ranges for all of the reagents used in the study. Reference ranges will be constructed following the guidelines specified in CLSI Standard C28-A3c. All blood samples drawn for this study will use venous blood. Whole blood is not used for these studies; only citrated or heparinized samples are used. All samples are repeated twice (run in duplicate tests). Quality Controls are run on both instruments at a frequency specified by the manufacturers. Results obtained from this testing are not used to make treatment decisions.

    NCT ID:

    NCT01790386

    Who can I contact for additional information about this study?

    Rochester: Mark Ereth, MD 507-255-4235
                        


  5. MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

    Rochester, Minn. View Summary

    MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The study was initially designed as a randomized trial. Due to difficulty of enrollment, the study was amended and converted to an observational comparative study with study arm being self-selected by the patient.

    NCT ID:

    NCT01315145

    IRB Number:

    14-003187

    Who can I contact for additional information about this study?

  6. MASK stands for Mayo Anesthesia Safety in Kids study. Sometimes small children need to go to sleep for an operation (this is called “anesthesia”). This study will help us learn if anesthesia in small children causes later problems with learning and memory.

    Rochester, Minn. View Summary

    MASK stands for Mayo Anesthesia Safety in Kids study. Sometimes small children need to go to sleep for an operation (this is called “anesthesia”). This study will help us learn if anesthesia in small children causes later problems with learning and memory.

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Other people have found that when baby animals (mice, rats, monkeys and others) get anesthesia, sometimes it can change their brains and cause problems with learning later in life. Other people, including us, have looked at the records of kids who needed anesthesia as babies and toddlers. Some, but not all, of these studies seem to show that kids who need anesthesia are more likely to have problems with learning when they start school. But there are some problems with these studies, and it is hard to tell whether or not anesthesia is really causing problems. In this new study, we will do some special tests that will help us know whether anesthesia is causing any problems or not.

    IRB Number:

    12-005564

    Who can I contact for additional information about this study?

    If you would like more information, please contact:
    Shonie Buenvenida, RN Study Coordinator
    (507)255-1558
    E-mail: RSTMASK@mayo.edu