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
studyfinder@utsouthwestern.edu
Peter Szmuk
80418
All
up to 2 Years old
Phase 3
NCT03089905
STU 052017-065
Drug: Sevoflurane, Drug: Remifentanil, Drug: Dexmedetomidine
Neurotoxicity, Anesthesia, Child Development
Children’s Health
Enhanced Recovery After Bilateral Reduction Mammaplasty
This single-center, clinical trial is being conducted to determine whether non-narcotic pain
regiments are as effective as narcotic-based regiments in reducing post-operative pain in
patients undergoing breast reduction in the outpatient setting.
Call 214-648-5005
studyfinder@utsouthwestern.edu
studyfinder@utsouthwestern.edu
Jeffrey Kenkel
18673
Female
18 Years and over
N/A
NCT04558840
STU-2020-0813
Procedure: Macromastia
Pain
UT Southwestern
ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
This study aims to be a randomized, controlled study of ANI-guided opioid administration
versus standard clinical practice in surgical patients undergoing general anesthesia with
balanced sevoflurane-fentanyl. Patients will be randomly assigned to 2 groups- ANI vs.
standard care. The intraoperative and postoperative management of all patients will be
standardized by protocol. The PACU nurses and postop assessor will be blinded as to which
group the patient is in.
Call 214-648-5005
studyfinder@utsouthwestern.edu
studyfinder@utsouthwestern.edu
Tiffany Moon
66760
All
18 Years to 75 Years old
N/A
NCT03684590
STU-2018-0096
Device: ANI-guided opioid administration, Other: Standard opioid administration
Acute Pain
Parkland Health & Hospital System
Interscalene Bupivacaine With Either Liposomal Bupivacaine or Continuous Peripheral Nerve Block for Shoulder Arthroscopy
This investigation will be a prospective, randomized trial. The study population will consist
of adult patients scheduled to undergo major shoulder arthroscopy procedures with
anesthesiology at the Ambulatory Services Center (Outpatient Surgery Center). Forty-six
subjects will be enrolled in this study and will be randomized into one of two arms: 1)
Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB, 2) Single-injection
bupivacaine HCl plus liposomal bupivacaine included in the same injection. These procedures
will take place, using an ultrasound-guided method, approximately one hour prior to surgical
procedure. Subjects will be followed for seven days to assess pain control by the Modified
Brief Pain Inventory (MBPI) survey and outcome factors related to study and procedure using
the American Shoulder and Elbow Surgeon Shoulder Score (ASES Shoulder Score).
Call 214-648-5005
studyfinder@utsouthwestern.edu
studyfinder@utsouthwestern.edu
Anthony Machi
159003
All
18 Years and over
N/A
NCT03816982
STU 082018-017
Procedure: Single-injection bupivacaine HCl plus liposomal bupivacaine, Procedure: Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB
Shoulder Pain
UT Southwestern
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
studyfinder@utsouthwestern.edu
Nitin Jain
186541
All
21 Years to 100 Years old
N/A
NCT03752619
STU-2020-0352
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
Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients (BTIGER)
The purpose of this study is to investigate the relationship between BIS™ values including
EEG profile and anesthetic agents in the pediatric population
Call 214-648-5005
studyfinder@utsouthwestern.edu
studyfinder@utsouthwestern.edu
Gijo Alex
172524
All
4 Years to 18 Years old
N/A
NCT04810481
STU-2021-0578
Device: BIS Complete Monitoring System
Anesthesia
Children’s Health
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
studyfinder@utsouthwestern.edu
John Alexander
52265
Female
18 Years to 80 Years old
N/A
NCT04074226
STU-2019-1174
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
The Effectiveness of Aromatherapy in an Urban, Safety-Net Hospital on Pain
The purpose of this project is to evaluate the effectiveness of aromatherapy on reducing pain
in the acute care setting at Parkland Health and Hospital System. The target population for
this study will be patients who are recovering from surgical procedures and are in the
Surgical Services inpatient units.
Call 214-648-5005
studyfinder@utsouthwestern.edu
studyfinder@utsouthwestern.edu
Justin Buchert
All
18 Years and over
N/A
NCT04840212
STU-2020-1176
Other: Lavender-Sandalwood scented aromatherapy sticker
Pain Management
Parkland Health & Hospital System
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
studyfinder@utsouthwestern.edu
Nader Pouratian
205161
All
18 Years and over
NCT04502550
STU-2021-0396
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