Clinical Trials

Clinical Trial – Incidence of Postoperative Delirium in Cancer Patients After Laparoscopic Surgery in Trendelenburg Position

Postoperative delirium is an acute mental syndrome that is caused by diffuse cerebral
dysfunction resulting from the action of predisposing and precipitating factors acting
together. It is associated with an increase in mortality and postoperative morbidity and
prolongs the period of hospitalization of the patient Videolaparoscopic surgery has been
increasingly used as a therapeutic and diagnostic method. In order to have a good
visualization of the anatomical structures on which it will act, it is necessary to introduce
gas into the cavity, a mandatory component known as pneumoperitoneum. This technique gives
special characteristics for the conduction of anesthesia, since the positive intra-abdominal
pressure results in changes in the patient’s physiology. Some types of laparoscopic surgery
require the position of Trendelenburg for better visualization of the operative field. Among
the changes related to this position are the increase in cardiac output and intracranial
pressure.

In order to optimize the anesthetic procedure, anesthetic blocks have been increasingly used,
especially the spinal. The association of general anesthesia with spinal anesthesia, followed
by its contraindications is advantageous, because lower doses of anesthetic agents are
necessary for the maintenance of general anesthesia. This association results in an earlier
awakening, a reduction of nausea / vomiting, postoperative pain, length of hospital stay,
cost effectiveness and greater patient satisfaction. As a disadvantage, by associating
general anesthesia with spinal anesthesia, patients become susceptible to the adverse events
of spinal anesthesia. Among these, the most common are headache, hypotension, nausea and
vomiting, pruritus, urinary retention and tremor. Performing spinal anesthesia with opioids
alone, without the use of local anesthetic is also possible, with morphine being the most
used. The benefit of this variation of technique is analgesia for a period of 12 to 24 hours,
without the cardiovascular consequences resulting from the action of the local anesthetic.

JUSTIFICATION: There are no studies in the literature evaluating The objective of this study
is to analyze if the anesthetic techniques employed, general anesthesia or general anesthesia
associated with subarachnoid block, for videolaparoscopic oncologic surgeries, in
Trendelenburg position, differ in relation to the incidence of delirium in the postoperative
period.

Clinical Trial – Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke

Background and Rationale:

Cerebrovascular disease is always ranked at the top causes of death and most of hospitalized
acute stroke patients have ischemic stroke [1].

Although the mortality rate of acute ischemic stroke is less than that of hemorrhagic stroke
[1], it still results in patient disabilities and complications that often lead to
significant costs to individuals, families, and society.

Traditional treatment for acute ischemic stroke includes thrombolytic therapy by injecting
tissue plasminogen activator (t-PA) within three hours after onset of symptoms [2],
antiplatelets and/or anticoagulant agents administered within the first 48 hours. Clinically,
the narrow time window of thrombolytic therapy and coexisting contraindications limit the use
of t-PA [2]. Thus, searching for an effective supplemental treatment for acute ischemic
stroke is imperative.

Hyperbaric oxygen therapy (HBOT) is valuable in treating acute carbon monoxide poisoning
[3,4], air or gas embolism [5], facilitating wound healing [6] and has been used as an
adjuvant treatment for many neurological disorders that need further study as concussion [7]
, stroke [8,9], cerebral palsy [ 10],traumatic brain injury [ 11], cerebral air embolism
[12], Autism [13] and multiple sclerosis [14].

Indications of hyperbaric oxygen therapy recommended by undersea and hyperbaric medical
society (UHMS) [15] are 1.air or gas embolism [5], 2.carbon monoxide poisoning [3,4],
3.clostridial myositis and myonecrosis [16], 4.crush injury, compartment syndrome and other
acute traumatic ischemias [17], 5.decompression sickness [18], 6.arterial insufficiencies
[19], 7.severe anemia [20], 8.intracranial abscess [21], 9.necrotizing soft tissue infections
[22],10. refractory osteomyelitis [23], 11.delayed radiation injury [24], 12.compromised
grafts and flaps [25], 13.acute thermal burn injury [26] and 14.idiopathic sudden
sensorineural hearing loss [27].

Known mechanisms of HBOT-induced neuroprotection include enhancing neuronal viability via
increased tissue oxygen delivery to the area of diminished blood flow, reducing brain edema,
and improving metabolism after ischemia [28,29]. Furthermore, a recent study performed on a
rat suggested that upregulation of the expression of glial derived neurotrophic factor (GDNF)
and nerve growth factor (NGF) might underlie the effect of HBOT [30].

The effectiveness of use of Hyperbaric oxygen therapy in human ischemic stroke is still
controversial that need further evaluation.

Clinical Trial – Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

This is a randomized, single blinded, non-placebo controlled that will compare one group of
Bells Palsy patients receiving the current standard of care including oral corticosteroids
and oral antivirals against an experimental group receiving the current standard of care in
addition to hyperbaric oxygen therapy. Outcome assessment will be based on both objective
analyses of facial movements as well as subjective quality of life scales.

Clinical Trial – Accelerated Hypofractionated Intensity – Modulated Radiotherapy After Hyperbaric Oxygenation for Recurrent High Grade Glioma.

This is a pilot study of radiotherapy using Hypofractionated image – guided helical
tomotherapy after hyperbaric oxygen HBO therapy for treatment of recurrent malignant
High-grade gliomas. HBO therapy will be perform in conjunction with each RT session.

The treatment scheme is:

Hyperbaric oxygenation therapy (the maximum period of time from completion of decompression
to RT is 60 min) followed by tomotherapy (3-5 consecutive sessions- one fraction per day , 5
Gy / die ).

The trial will enroll 24 patients in 24 months with a follow-up period of 1 year.

Clinical Trial – Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma

Patients with Multiple Myeloma who are considered for high-dose therapy and autologous
transplantation at the bone marrow transplant clinic at the Wilmot Cancer Institute (WCI)
will be be approached to participate in this trial. Eligible patients who choose to
participate will be randomized so that half receive one hyperbaric oxygen therapy session
prior to hematopoetic stem cell infusion and half will not. All subjects will have their
blood counts monitored closely and time to count recovery will be compared between the two
groups.

Clinical Trial – Decompression Tables for Diving at Altitude

The aims of this proposal are to test current USN procedures for adjusting decompression
procedures during air diving at 8,000 and 10,000 ft altitude and to provide a decompression
algorithm for no-stop dives to 100 feet of sea water (fsw) at 10,000 and 12,000 ft altitude
using enriched O2 (PO2=1.3 ATM). Additionally, the experiments will determine whether a
period of hyperbaric hyperoxia, such as would be experienced during a dive at altitude,
reverses altitude acclimatization, resulting in a return of acute mountain sickness (AMS)
symptoms.

Clinical Trial – Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine

56 Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive
sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate
(normal sequential) NS or a rapid intrathecal injection of fentanyl followed by slow
injection of hyperbaric bupivacaine (rapid sequential) RS. Time of first rescue analgesia,
Dose of rescue analgesics, degree of postoperative pain, incidence of hypotension,
hypotension duration, ephedrine dose, spinal anaesthesia related complications and failed
block were recorded.

Clinical Trial – Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant

The planned cesarean section is an intervention with a standard operating time of less than
40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference
for these operations. But the duration of its motor block is generally greater than 3 hours.
The purpose of this study is to show a reduction in motor block time with hyperbaric
Prilocaine by at least 30 minutes, which would allow mothers and their children to return to
the maternity ward earlier and thus improve the circulation of patients within the
maternity’s PACU.

Clinical Trial – Hyperbaric Oxygen Therapy in Sickle Cell Pain

Hyperbaric oxygen therapy in acute sickle cell pain crisis. The purpose of this study is to
explore if hyperbaric oxygen therapy would decrease hospital length of stay and pain
associated with acute sickle cell pain crisis. Eligibility criteria include both female and
males age 19 years or older with sickle cell who are in an acute pain crisis. Exclusions
include pregnancy and a sickle cell crisis complicated by any acute significant concomitant
factors/conditions (i.e., acute chest syndrome, acute MI/stroke). Interventions would be 1-3
hyperbaric oxygen sessions depending on response to the therapy. Each treatment session will
be approximately two hours in length. Evaluation would be through patients’ self assessment
via the visual analog scale for pain level before and after treatments as well as tracking
length of stay in the hospital.

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