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5 Study Matches

A Study to Compare the Long-term Outcomes After Two Different Anaesthetics (TREX)

There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Kiley.Poppino@UTSouthwestern.edu
Peter Szmuk
80418
All
up to 2 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03089905
STU 052017-065
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Inclusion Criteria:

• Younger than 2 years (chronological age)
• Scheduled for anaesthesia that is expected to last at least 2 hours (and/or total operating room time is scheduled to be at least 2.5 hours)
• Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Exclusion Criteria:

• Known neurologic, chromosomal or congenital anomaly which is likely to be associated with poor neurobehavioural outcome
• Existing diagnosis of behavioural or neurodevelopmental disability
• Prematurity (defined as < 36 weeks gestational age at birth)
• Birth weight less than 2 kg.
• Congenital cardiac disease requiring surgery
• Intracranial neurosurgery and intracranial craniofacial surgery (isolated cleft lip is not an exclusion)
• Previous cumulative exposure to general anaesthesia exceeding 2 hours
• Planned future cumulative exposure to anaesthesia exceeding 2 hours before the age of 3 years.
• Any specific contra-indication to any aspect of the protocol
• Previous adverse reaction to any anaesthetic
• Circumstances likely to make long term follow-up impossible
• Living in a household where the primary language spoken at home is not a language in which we can administer the Wechsler Preschool and Primary School Intelligence Scale
• Planned postoperative sedation with any agent except opioids (e.g. benzodiazepines, dexmedetomidine, ketamine, barbiturates, propofol, clonidine, chloral hydrate, and other non-opioid sedatives). For example if such sedation is planned for post-operative ventilation
Drug: Sevoflurane, Drug: Remifentanil, Drug: Dexmedetomidine
Neurotoxicity, Anesthesia, Child Development
Children’s Health
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Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)

Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail treatment efforts and have longstanding pain. This project will evaluate the efficacy of a novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS).
Call 214-648-5005
studyfinder@utsouthwestern.edu, Mark.Newman@UTSouthwestern.edu
Nitin Jain
186541
All
21 Years to 100 Years old
N/A
This study is also accepting healthy volunteers
NCT03752619
STU-2020-0352
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Inclusion Criteria:
1. Shoulder pain of >3 months 2. Age>=21 3. Worst pain in the last week>=4 (0-10 scale) 4. Ability to check skin and perform dressing changes, independently or with assistance 5. Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid analgesic)
Exclusion Criteria:
1. Current shoulder joint or overlying skin infection, or current bacterial infection requiring antibiotics 2. Other chronic pain syndrome (Pain in another area of the body 15 or more days in the last 30 (more than half of the time) or taking daily analgesics for another pain syndrome) 3. Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff, acromioclavicular (AC) Joint, etc.) 4. Corticosteroid injection in the ipsilateral shoulder or any other pain relieving treatment in last 12 weeks 5. Uncontrolled bleeding disorder 6. Medical instability based on physician opinion after review of medical information 7. Pregnancy 8. Neurological condition affecting ipsilateral upper limb (such as central neurologic injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome, etc.) 9. Current Worker's compensation claim for the ipsilateral shoulder 10. Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms and physical examination 11. Ipsilateral shoulder injury due to severe trauma (Fall from greater than standing height; Motor vehicle crashes; Struck by vehicle or other fast-moving projectile (e.g., bullet, baseball, etc.); Assault (i.e., injuries intentionally inflicted by another person)) 12. Current osseus fracture in ipsilateral arm 13. Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or full) 14. Surgical indication for shoulder treatment based on physician opinion 15. Compromised immune system (immunodeficiency or immunosuppression) 16. Current use of a Deep Brain Stimulation (DBS) system, implanted active cardiac implant (e.g. pacemaker or defibrillator), any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System 17. Patients who have a tape or adhesive allergy 18. Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body habitus, etc)
•exclude from Magnetic resonance imaging (MRI) only
Device: Contracting Producing Peripheral Nerve Stimulation, Device: Non Contracting Producing Peripheral Nerve Stimulation, Other: Physical Therapy
Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Tendinitis, Shoulder Bursitis, Pain, Shoulder
peripheral nerve stimulation, Sprint, stimulation
UT Southwestern
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Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial) (PEAC)

The purpose of this study is to evaluate the hemodynamics and adverse event profile in comparison between two treatment arms, one using an admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7), and one using an admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2), for anesthesia during endoscopic procedures at the Clements University Hospital (CUH) endoscopy lab (Endo).
Call 214-648-5005
studyfinder@utsouthwestern.edu, Emily.Melikman@UTSouthwestern.edu
Joseph Hendrix
84601
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05358535
STU-2022-0377
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Inclusion Criteria:
1. Adult patients (age ≥18 years old) 2. Having endoscopic procedure at CUH with anesthesia 3. ASA 3 or above 4. Ejection Fraction test result available
Exclusion Criteria:
1. Known allergies or adverse reactions to study drugs or study drug components or preservatives 2. Patient refusal 3. Clinician refusal 4. Documented cognitive impairments precluding subject ability to consent for themselves unless a surrogate documented legally acceptable decision maker consents for patient participation 5. Prisoner or incarcerated or patients held by law enforcement officials in custody 6. Pregnancy or patient refusal for pregnancy testing or screening (standard UTSW policy and protocol requires pregnancy testing for appropriate patients prior to anesthesia)
Drug: Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2), Drug: Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7)
Anesthesia, Propofol Adverse Reaction, Etomidate Adverse Reaction, Anesthesia Complication, Anesthesia, Adverse Effect, Anesthesia, Reaction
anesthesia, anesthesiology, adverse drug reaction, drug side effect, sedation, cardiopulmonary, hemodynamics
UT Southwestern
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ESP vs QL for Total Abdominal Hysterectomy

Patients undergoing open total abdominal hysterectomy (n=82) at Parkland Memorial Hospital will be randomized into one of two groups to receive either ultrasound-guided bilateral ESP block with liposomal bupivacaine (Group 1) or ultrasound-guided bilateral QL block with liposomal bupivacaine (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the general anesthetic technique and postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 72 hours postoperatively. Anesthesia providers will identify potential subjects during their Pre-Anesthesia Evaluation Clinic visit and/or Day Surgery Unit pre-anesthetic assessment. There will be no incentive or payment to the patients. Patients in Group 1 will receive ultrasound-guided bilateral ESP block in the preoperative holding area prior to surgery. Patients in Group 2 will receive ultrasound-guided QL block in the preoperative holding area prior to surgery. All patients will have general anesthesia per previously established Parkland Enhanced Recovery After Surgery (ERAS) protocols. Postoperatively, patients in both Groups will receive acetaminophen 1000 mg orally every 8 hours, meloxicam 15 mg orally every 24 hours, and immediate-release oxycodone 5 - 10mg orally every 4 hours as needed for breakthrough pain. The postoperative analgesia will be documented using the Numeric Rating Scale (0-10 scale where 0=no pain and 10=worst pain). In addition, total opioid dose over the 72-hours study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue anti-emetics will be given to any patient who complains of nausea and/or vomiting. All variables will be assessed at 4, 6, 12, 24, 48, and 72 hours, postoperatively by an investigator blinded to group allocation.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Farzin.Ahmed@UTSouthwestern.edu
John Alexander
52265
Female
18 Years to 80 Years old
N/A
This study is also accepting healthy volunteers
NCT04074226
STU-2019-1174
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Inclusion Criteria:

• Female ASA physical status 1-3 scheduled for open abdominal hysterectomy
• Age 18-80 years old
• Able to participate personally or by legal representative in informed consent in English or Spanish
Exclusion Criteria:

• History of relevant drug allergy
• Age less than 18 or greater than 80 years
• Chronic opioid use or drug abuse
• Active use of anticoagulant medication
• Significant psychiatric disturbance
• Inability to understand the study protocol
• Refusal to provide written consent
Procedure: Erector Spinae Plane block, Procedure: Quadratus Lumborum Block
Postoperative Pain
regional anesthesia, postoperative pain, erector spinae plane block, quadratus lumborum block
Parkland Health & Hospital System
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Brain Networks and Consciousness

General anesthesia (GA) is a medically induced state of unresponsiveness and unconsciousness, which millions of people experience every year. Despite its ubiquity, a clear and consistent picture of the brain circuits mediating consciousness and responsiveness has not emerged. Studies to date are limited by lack of direct recordings in human brain during medically induced anesthesia. Our overall hypothesis is that the current model of consciousness, originally proposed to model disorders and recovery of consciousness after brain injury, can be generalized to understand mechanisms of consciousness more broadly. This will be studied through three specific aims. The first is to evaluate the difference in anesthesia sensitivity in patients with and without underlying basal ganglia pathology. Second is to correlate changes in brain circuitry with induction and emergence from anesthesia. The third aim is to evaluate the effects of targeted deep brain stimulation on anesthesia induced loss and recovery of consciousness. This study focuses on experimentally studying these related brain circuits by taking advantage of pathological differences in movement disorder patient populations undergoing deep brain stimulation (DBS) surgery. DBS is a neurosurgical procedure that is used as treatment for movement disorders, such as Parkinson's disease and essential tremor, and provides a mechanism to acquire brain activity recordings in subcortical structures. This study will provide important insight by using human data to shed light on the generalizability of the current model of consciousness. The subject's surgery for DBS will be prolonged by up to 40 minutes in order to record the participant's brain activity and their responses to verbal and auditory stimuli.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Lillian.Whipple@UTSouthwestern.edu
Nader Pouratian
205161
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04502550
STU-2021-0396
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Inclusion Criteria:

• Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes
• Clinical diagnosis of Parkinson's disease or essential tremor
• Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
Exclusion Criteria:

• Patients with recent use (within one week) of anticoagulant or antiplatelet agent use
• Neurocognitive testing indicating amnestic cognitive deficits
• History of intolerance of propofol or medical indications to use an anesthetic other than propofol
Drug: Propofol
Parkinson Disease, Anesthesia, Essential Tremor, Brain and Nervous System, Loss of Consciousness
general anesthesia, deep brain stimulation, basal ganglia, thalamus, sensorimotor cortex
UT Southwestern
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