Clinical Trials

Clinical Trial – Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance

Obesity is an epidemic in Western society and is the biggest risk factor for insulin
resistance and type 2 diabetes. The investigators have preliminary evidence showing that
hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires
confirmation in a larger population, and with this study the investigators will also test for
mechanisms how this occurs. The investigators suspect that modulation of hypoxia and stress
response proteins following changes in tissue oxygenation may contribute to these
improvements. This study has the potential to yield new and important insights into the
insulin resistance in obesity.

Clinical Trial – Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery

Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia
technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been
validated for this surgery. Both selective techniques are specially indicated for ambulatory
surgery because of PACU fast track, low discharge home time and high patient satisfaction.
This study compares both spinal techniques for knee arthroscopy surgery.

Clinical Trial – Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

The authors would like to investigate the blocking characteristics, surgical quality and side
effects of intrathecal levobupivacaine whether there are any differences between the
hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block
level than the urological surgeries.

Clinical Trial – The Effects of Intrathecal Dexmedetomidine on Spinal Anesthesia Using Diluted Low-Dose Bupivacaine for Transurethral Resection of Prostate in Elderly

Spinal block is the most common anesthetic technique for transurethral resection of
prostatectomy (TURP). Most patients undergoing TURP are elderly and frequently present with
cardiopulmonary and endocrine diseases. Low-dose local anesthetic is commonly administer to
limit the block level to minimize the hemodynamic changes. However, sometimes it may not
provide an adequate level of sensory block. Thus, intrathecal additive is frequently
administer with local anesthetic to improve analgesic effect.

Dexmedetomidine(DXM), a selective 2-adrenoreceptor agonist, has been used in the epidural
space in humans without any reports of neurological deficits. Previous clinical studies
showed that intravenous dexmedetomidine administration prolonged the sensory and motor blocks
of bupivacaine spinal analgesia. But clinical studies about the use of intrathecal DXM with
local anesthesia in humans are scarce in the literature. Kanazi et al. found that 3μg DXM
added to 12 mg spinal bupivacaine produced the significant short onset of sensory and motor
block as well as significantly longer duration of sensory and motor block than bupivacaine.
And Al-Mustafa et al. reported that intrathecal dexmedetomidine as an adjuvant to 12.5mg
bupivacaine in spinal anesthesia has a dose dependant effect on the onset and regression of
sensory and motor block.

In our previous study, low-dose diluted bupivacaine 5 mg provided sufficient anesthetic level
when opioid was added with local anesthetic. However, opioid-induced side effects, such as
pruritus, nausea, or vomiting, could be an obstacle in common use. The aim of this study is
to evaluate whether DXM-low-dose bupivacaine spinal anesthesia can provide the effective
spinal anesthesia and postoperative analgesia with minimal side effect compare to the local
anesthetic only group.

This study was conducted in a randomized, double-blind, controlled fashion. Patients were
randomly allocated to DXM group or Saline group. DMT group received hyperbaric bupivacaine
0.5% (1.2 ml) (6 mg) in dextrose 8% solution + DMT 0.3 ml (3 µg)-in total, bupivacaine 0.4%
(1.5 ml) intrathecally and Saline group received hyperbaric bupivacaine 0.5% (1.2 ml) (6 mg)
in dextrose 8% solution + normal saline 0.3 ml -in total, bupivacaine 0.4% (1.5 ml)
intrathecally. After spinal block, the level of sensory block, defined as the dermatomal
segment with loss of pain sensation to pin-prick with a 22 G hypodermic needle and cold
sensation to alcohol swab was measured every 2 min after intrathecal injection. The
investigators recorded the peak sensory block level, time to peak block level from
intrathecal injection, blood pressure and heart rate, and analgesic supplementation during
operation. The maximum motor block level was assessed according to the modified Bromage
scale. During postoperative period, the frequency of analgesic requirement, time to the first
analgesic request, and pain scores were evaluated by blind investigator.

Clinical Trial – Hyperbaric Oxygen Therapy (HBO2) for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (mTBI)

This is a Phase II randomized trial designed to describe the magnitude of change between
baseline and follow-up outcomes for symptom surveys and a battery of neuropsychological tests
administered at time points corresponding before and after 10 weeks over observation in four
groups:

– A military population with post-concussion syndrome (mTBI) receiving local standard care

– A military population with post-concussion syndrome (mTBI) receiving local standard care
and sham hyperbaric oxygen sessions

– A military population with post-concussion syndrome (mTBI) receiving local standard care
and hyperbaric oxygen at 1.5 atmospheres sessions

– A otherwise similar group with PTSD but no history of TBI receiving local standard care
Differences and variability of the tests will be used for determining the optimum
primary endpoint(s) for future trial, as well as for refinement of sample size and power
calculations for these studies. The groups undergoing hyperbaric sessions will be
assigned to receive HBO2 or sham using a randomized, double blind design.

Active duty military (Army, Marine, Navy, Air Force) men and non-pregnant women residing in
the United States and who will remain in the military for the entire study period, aged 18-65
years who have been deployed one or more times to the US Central Command since the initiation
of Operation Enduring Freedom (October 7, 2001) who either:

– have been diagnosed with Post Traumatic Stress Disorder (PTSD) as a result of traumatic
events that occurred during the qualifying CENTCOM deployment, but have no diagnosed or
suspected lifetime brain injuries resulting in loss or alteration of consciousness; OR

– have been diagnosed with at least one mild brain injury (mTBI) with persistent (> 4
months) symptoms sustained during one or more of those deployments

Clinical Trial – Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury

The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant
treatment for frost damage.

The investigators hope to include at least 20 patients in a randomized manner. Half of the
patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to
have hyperbaric oxygen treatment.

Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as
adjuvant treatment for frost damage. The functional level of the frost damaged patient is
better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost
damage.

Clinical Trial – Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate?

This study aims to test the hypothesis that postoperative daily hyperbaric oxygen therapy
(HBOT) decreases soft-tissue complication rate during the operative handling of
intra-articular calcaneal fractures. Minor motivations: 1. To evaluate microcirculatory
criteria of cutaneous tissue predicting emerging wound healing defects, 2. To identify
patients at risk for soft-tissue complication after calcaneal plate osteosynthesis and to
determine the optimal time point for operative intervention using these microcirculatory
criteria preoperatively, 3. To evaluate the effect of HBOT on postoperative microcirculation,
4. To collect preliminary data to evaluate the economical impact of wound complications, with
and without HBOT, 5. To identify a correlation between HBOT with expected limited soft-tissue
complication rate and the clinical and radiographic outcome two years after surgery.

Clinical Trial – The Effects of Intravenous Dexmedetomidine on Spinal Anesthesia Using Low Dose Diluted Bupivacaine for Transurethral Resection of Prostate

Dexmedetomidine is a new selective and potent alpha-2 agonist. It has centrally acting
anesthetic properties. It has been known that intrathecal addition of alpha-2 adrenergic
agents result in prolongation of the duration of the sensory and motor blockade induced by
hyperbaric bupivacaine. But the effects of intravenous dexmedetomidine on the spinal block
was not evaluated. The aim of study is to assess the effect of intravenous dexmedetomidine on
the low-dose spinal anesthesia for the transurethral surgery.

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