Peri-operative outcomes in patients with OSA undergoing sinonasal surgery + save

Date Added
May 10th, 2013
PRO Number
Pro00022724
Researcher
Zachary Soler
Keywords
Nose, Sleep Disorders, Surgery
Summary

The goal of this study is to better understand peri-operative outcomes in patients with obstructive sleep apnea (OSA) undergoing sinonasal surgery. Specifically, this study will examine oxygen saturation levels and need for supplemental oxygen during the first night following surgery. The tolerance of continuous positive airway pressure (CPAP) therapy in the weeks following surgery will also be assessed.

Institution
MUSC
Recruitment Contact
Kristina Storck
843-792-9496
storck@musc.edu

PEDIATRIC HEART NETWORK LONGITUDINAL FONTAN STUDY (FONTAN 3) + save

Date Added
May 7th, 2013
PRO Number
Pro00017096
Researcher
Andrew Atz
Keywords
Cardiovascular, Exercise, Genetics, Heart, Pediatrics, Surgery
Summary

A follow-up study (Fontan 2) at an average of 6 years after Fontan 1 has recently been completed. A limited re-evaluation of the original Fontan 1 cohort utilized the following outcomes: vital status, functional health status, interim medical events, access to health care and self-reported availability and willingness to participate in future studies. We are continuing to follow this unique group of individuals in order to assess how they are coping with this chronic disease process.

Institution
MUSC
Recruitment Contact
Patricia Infinger
843-792-7857
infingep@musc.edu

Transcranial Direct Current Stimulation in the Management of Post-operative Pain + save

Date Added
March 5th, 2013
PRO Number
Pro00015412
Researcher
Jeffrey Borckardt
Keywords
Pain, Surgery
Summary

This study, sponsored by the Medical University of South Carolina, will investigate whether a new medical technology can help reduce post-operative pain in patients undergoing total knee replacements. The new technology is called Transcranial Direct Current Stimulation (tDCS) and uses a very small amount of electricity to temporarily stimulate specific areas of the brain. The electrical current passes through the skin, scalp, hair, and skull and can temporarily increase or decrease activity in the areas of the brain that are thought to be involved in pain reduction. The tDCS sessions last 20 minutes, and patients will be asked to report pain ratings.

Institution
MUSC
Recruitment Contact
Molly Hook
(843) 792-3127
hookm@musc.edu

Randomized, Double-Blind, Placebo-Controlled Trial of Lacosamide for Seizure Prophylaxis in Patients with High-Grade Gliomas + save

Date Added
March 1st, 2013
PRO Number
Pro00016182
Researcher
Pierre Giglio
Keywords
Cancer/Brain, Surgery
Summary

This study is for subjects who have or may have seizures, or may be at risk for seizures, after having had a surgery for brain cancer called
malignant glioma. The goal of this clinical research study is to learn if lacosamide can help to reduce the risk of seizures in patients with malignant glioma. In this study, lacosamide will be compared to a placebo. Lacosamide is designed to decrease abnormal electrical activity in the brain that plays a role in developing seizures. If subjects are found to be eligible to take part in this study, they will be randomly assigned (as in the flip of a coin) to receive either lacosamide or a placebo. Subjects may take lacosamide or placebo for up to 1 year. Their study doctor may take them off the study early if he or she feels it is not in their best interest, they have new health problems that make taking part in the study possibly dangerous, if intolerable side effects occur, or if they are unable to follow study directions.

Institution
MUSC
Recruitment Contact
Michele DeCandio
843-792-9016
decandio@musc.edu

Lidocaine For Neuroprotection During Cardiac Surgery + save

Date Added
February 5th, 2013
PRO Number
Pro00014030
Researcher
James Abernathy
Keywords
Stroke, Surgery
Summary

The primary aim of the study is to determine the effect of lidocaine infusion upon neurocognitive function after cardiac surgery. The study population will consist of 476 informed and consenting patients for cardiac surgery with cardiopulmonary bypass (CABG, Valve, or CABG + Valve) who will be prospectively enrolled over a four-year period (one-year for follow-up). Patients will be randomly assigned to one of two groups with all investigators and cognitive “testers” blinded to this assignment: lidocaine bolus & continuous infusion over 48 hours vs saline bolus & continuous infusion over 48 hours. After induction of anesthesia, patients randomized to the lidocaine group will receive a 1 mg/kg bolus of intravenous lidocaine, followed by an infusion at 48 mcg/kg/min for 1 hour, then 24 mcg/kg/min for the second hour, and then 10 mcg/kg/min for the next 46 hours. Plasma for lidocaine levels will be sampled at baseline (prior to bolus), end of cardiopulmonary bypass, and 24 and 48 hours after bolus (end of infusion). If plasma levels exceed 5 mcg/ml, the lidocaine infusion will be discontinued, thus safeguarding against delivery of supra-therapeutic or toxic doses. Patients randomized to the control group will receive a saline bolus followed by an infusion of normal saline with rate changes and plasma sampling points just as in the lidocaine treatment group. Cognitive testing will occur preoperatively (baseline), at six-weeks, and one year after surgery. An additional aim will be to determine the effect of lidocaine infusion upon short and long-term quality of life. Our proposed approach to measurement of quality of life for this study involves the use of a battery of well-tested and well-validated instruments that together cover the relevant domains of interest.

Institution
MUSC
Recruitment Contact
Peggy Edgerton
8437921869
edgerp@musc.edu

Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy + save

Date Added
January 15th, 2013
PRO Number
Pro00013103
Researcher
Sylvia Wilson
Keywords
Joint, Pain, Surgery
Summary

Patients who choose to participate will still receive their standard anesthesia and surgical evaluation. They will be given a randomized dose of ketorolac (7.5, 15 or 30 mg) or saline. In the operating room, all patients will receive a standard anesthetic for knee arthroscopy including general anesthesia and monitoring. In recovery, all patients will have access to medications as needed for pain, nausea, itching or other anesthetic or surgically related issues. Patients will be asked to report their pain scores to the nurses and doctors caring for them.

Institution
MUSC
Recruitment Contact
Peggy Edgerton
843-792-1869
edgerp@musc.edu

Does the intraoperative use of the FloTrac device to guide fluid and vasopressor management affect postoperative morbidity in patients receiving a head and neck microvascular free tissue transfer? + save

Date Added
December 18th, 2012
PRO Number
Pro00013643
Researcher
William Hand
Keywords
Surgery
Summary

This study aims to investigate whether the intraoperative use of the FloTrac device to guide fluid and vasopressor management during head and neck free flap surgery improves postoperative outcome. Primary postoperative outcome is length of hospital stay. Secondary postoperative outcomes include days in ICU, days on ventilator, presence of postoperative pulmonary edema, need for postoperative vasopressors or transfusions, 30 day flap complication rate, inpatient postoperative cardiorespiratory complications/events, and overall 30 day flap failure rate.

Institution
MUSC
Recruitment Contact
Simone Chinnis
843-792-1869
chinniss@musc.edu

Roles of intratumor macrophages and the master chaperone for Toll-like receptors in colon cancer + save

Date Added
October 30th, 2012
PRO Number
Pro00010913
Researcher
Zihai Li
Keywords
Cancer, Cancer/Other, Men's Health, Minorities, Non-interventional, Surgery, Women's Health
Summary

This study will help to understand the roles of the immune system in controlling colon cancer. It may advance science, leading to future development of an effective treatment of colon cancer.

Institution
MUSC
Recruitment Contact
Zihai Li
843-792-1034
zihai@musc.edu

INSITE: Investigation of Sacroiliac Fusion Treatment + save

Date Added
October 23rd, 2012
PRO Number
Pro00019849
Researcher
John Glaser
Keywords
Joint, Surgery
Summary

The iFuse Implant System® (iFuse device) is a surgically implanted medical device that is implanted into a patient's sacroiliac (SI) joint during a minimally invasive procedure. The purpose of implanting the device is to stabilize and fuse the patient's SI joint. The iFuse device is cleared by the US Food and Drug Administration (FDA) for use in patients with degenerative sacroiliitis and SI joint disruption. The purpose of this study is to compare the outcomes of surgery with iFuse Implant System and non-surgical treatment.

Institution
MUSC
Recruitment Contact
Laura Fields
843-792-8385
coordinator@musc.edu

The Investigational Plan for the Evaluation of the ACADIA Facet Replacement System + save

Date Added
September 17th, 2012
IRB Number
20831
Researcher
Barton Sachs
Keywords
Pain, Surgery
Summary

This research study will enroll adults suffering from back and leg pain and difficulty walking from Lumbar Spinal Stenosis (LSS) who, as a part of their routine clinical care, are scheduled to have spinal surgery. This study will evaluate the safety and effectiveness of the ACADIA® Facet Replacement System, an FDA investigational device designed for LSS without fusion while maintaining the motion of the spine. This study will gather information about participants’ surgeries by reviewing their medical records and collecting responses on study questionnaires. All study data collection will occur during seven (7) routine care surgical clinical visits, where participants will also complete study questionnaires about their health status. Participation in this study is two (2) years plus additional annual follow up visits as required by the FDA.

Institution
MUSC
Recruitment Contact
Laura Fields
(843) 792-3131
fiela@musc.edu