The purpose of this study is to Compare three methods of intrathecal bupivacaine;
bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and
postoperative pain in patients undergoing lumbar disk herniation surgery.
Clinical Trials
Clinical Trial – Effects of Dexmedetomidine Premedication on Geriatric Patients With Chronic Renal Failure Undergoing Hip Surgery
Geriatric patients (age ≥ 65 years) undergo surgery for hip fractures that develops due to
osteoporosis and falls. Dialysis-dependent chronic kidney disease is associated with an
increased risk of cardiovascular comorbidity. Elective or urgent surgical operations may be
required for geriatric patients with end stage renal disease. These patients have severe
comorbidities, fluid, electrolyte disturbances and drug metabolism abnormalities during the
perioperative period. For this reasons a careful anesthesia plan should be planned and
performed. Spinal anesthesia can be used for hip fracture surgery at geriatric patients with
chronic renal failure. Anterograde femoral intramedullary nailing can be performed in supine
position with a fracture table. Intraoperative sedation might be necessary for patients under
regional anesthesia on traction table. Dexmedetomidine is an alpha 2 receptor agonist that is
being used as an agent for its sedative and adjuvant analgesic effects.
The aim of this study is to evaluate the effects of dexmedetomidine premedication on
geriatric patients with end stage renal disease, who will be undergoing a surgical operation
for hip fracture under spinal anesthesia with hyperbaric bupivacaine and BIS (Bispectral
Index) guided sedation with intraoperative propofol infusion.
Clinical Trial – The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn’s Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on
patient suffering from residual Crohn’s disease related perianal fistulas already treated
with TNF alpha blockers
Clinical Trial – Comparative Study Between Bilateral and Unilateral Spinal Anaesthesia
The purpose of this study is to compare unilateral spinal anesthesia using hyperbaric
Prilocaine with "classical bilateral spinal anesthesia" using plain Prilocaine according to
block characteristics and quality of micturition, standardized to the subjects own functional
bladder capacity. Our hypothesis is that unilateral spinal anesthesia will provide faster
time to micturtition and discharge, lesser hypotension and lesser micturition problems.
Clinical Trial – Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of
the fibrosis.
Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical
conditions including the treatment of delayed radiation injuries (soft tissue and bony
radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation
tissue and produces angiogenesis maintained after use.
Clinical Trial – Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.
Radiotherapy is the mainstay of treatment for brain malignancies and is associated with
significant neurotoxicity. Due to continuous increase in patient’s survival, the long term
risk for radiation-induced brain inflammation and necrosis inducing secondary cognitive
impairments are increasing concerns. Currently there is no effective treatment for preventing
long term radiation-induced brain damage.
Hyperbaric oxygen therapy (HBOT) is the administration of high oxygen concentrations within a
pressurized chamber to increase the cellular/mitochondrial delivery of oxygen. Oxygen
stimulation by HBOT has become the definitive therapy for radiation-induced damage to soft
tissues and bone due to its ability to stimulate healing processes by supplying the
energy/oxygen needed while down-regulating genes involved in inflammation. Oxygen stimulation
by HBOT is currently indicated for patients with overt radiation-induced neurotoxicity and
was proven to reduce further development of radiation damage while stimulating "idling"
neurons to return to function. Since HBOT is considered safe, we hypothesize that its
application following radiation, before the manifestation of neurological side effects, may
help avert development of early/delayed onset radiation-induced neurotoxicity.
In the proposed study, for the first time, HBOT will be applied early after radiation to
prevent the expected decrease in patients neurocognitive functions (NCF) and improve their
quality of life (QOL). The study is designed to provide statistically significant assessment,
in a prospective randomized clinical trial, of the effect of oxygen stimulation applied soon
after brain radiotherapy, for patients with primary and secondary brain tumors, on patients
QOL and NCF. In addition, advanced imaging methodologies will be applied to study the
feasibility of quantifying oxygen stimulation effects on the tumor and surrounding brain
tissue.
Clinical Trial – Tourniquet and Quadricepsforce
The purpose for this study is to investigate the quadriceps (thigh) function preoperatively
and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint)
in a randomised study with or without the use of a Tourniquet (cuff around the thigh during
surgery) (100 mm Hg > systolic blood pressure).
Clinical Trial – Intrathecal Magnesium for Same-day-surgery
5% hyperbaric lidocaine has lost its usefulness for same-day-surgery (SDS) anaesthesia
because it has been blamed responsible for the so-called transitory neurological syndrome
(TNS). This entity appears particularly in patients operated on lithotomy and knee
arthroscopy position and obese patients. It is a benign, moderately painful (grade 3-4 out of
10) and self-limited in time, but disturbing enough to be avoided in same-day-surgery cases.
Other local anesthetics are not competitive with general anesthesia in time to be discharged
home from the SDS unit. The magnesium ion is well-known for its protective properties on
cells with electrical activity. The objective is to confirm that the magnesium ion added as
adjuvant to intrathecal (IT) lidocaine may antagonize TNS incidence. If this hypothesis could
be confirmed, the practical and theoretical consequences would be far-reaching.
The method to achieve our objective would be a double-blinded randomized clinical trial
considering two groups of intrathecal lidocaine: with and without added IT magnesium.
Clinical Trial – Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture
There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft
fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack
of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during
flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal
pulses are late symptoms of ACS.
Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide
the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is
based on old patient-series and single case-reports. Some of these studies report the
symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions
in these studies cannot be confirmed by an expert of RA. It is also possible that there are
more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS.
There are no modern, randomized and controlled studies of the safety of RA in patients with
tibial shaft fracture.
Clinical Trial – A Study to Test the Safety of Combined Dosing With Aminophylline and Ambrisentan in Exercising Healthy Human Volunteers at Simulated High Altitude
Acute exposure of the unacclimatized human body to high altitude leads to health
complications, such as loss of exercise performance capacity and fatigue. The investigators
have found that the combination of the xanthine drug theophylline and the endothelin receptor
antagonist ambrisentan improves the exercise performance capacity of rats under simulated
high altitude. In young, healthy human volunteers, this combination of drugs has not increase
toxicity over the single compounds under sea-level conditions. The aim of this study is to
test whether the combination of theophylline, supplied as its more soluble formulation
aminophylline, and ambrisentan, are also safe to take under simulated high altitude of 4,267
meters, under both resting and exercising conditions. The study also aims to test whether
this drug combination improves exercise capacity in humans. In this study, human subjects
will be randomized to one of four treatment sequences and receive the same study drug(s)
throughout all procedures. The study consists of an initial exercise test, followed by two
cycles of drug testing at simulated high altitude: Cycle 1 – resting subjects receiving study
drug at simulated altitude and continually monitored for safety with pharmacodynamic and
pharmacokinetic assessments; and Cycle 2, the same as Cycle 1, with the addition of exercise
testing. It is hypothesized that the combination of aminophylline and ambrisentan is not only
safe under simulated high altitude, but also improves exercise performance capacity, in
comparison with placebo.