Clinical Trials

Clinical Trial – Hyperbaric Oxygenation in Treatment of Alcohol Dependence Syndrome

A 30 alcohol dependent patients were divided into A: Treatment group and B: Placebo group
using simple randomization technique. (Liver function tests) GGT, ALT and AST levels and MCV
(Mean corpuscular volume) at admission and 2 weeks later were estimated. Daily withdrawal
symptoms were assessed using the Clinical Institute Withdrawal Assessment scale (CIWA-Ar) and
DTs by Delirium Observation Screening (DOS) Scale (version 0 – 1). The data collected from
the two groups were compared.

Clinical Trial – Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk

An urgent need exists to identify effective interventions to arrest or reverse dementia and
cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will
investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive
functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive
impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen
therapy effects on cognition in diabetes. The potential to preserve, or even enhance,
cognition in elderly at high risk of cognitive decline and dementia has major implications
for the affected individuals and their support systems that bear the social and financial
burdens of long-term caregiving.

Clinical Trial – Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery

Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly
used for spinal injection in cesarean section. Nevertheless, its use often results in a long
duration of motor nerve block and a haemodynamical instability. Recently developped, the
Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for
hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for
intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the
effect of the local anesthetics while decreasing their dose-related side effects, the aim of
this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled
cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)

Clinical Trial – Body Mass Index and Post-dural Puncture Headache

Post-dural puncture headache (PDPH) is seen more frequently in pregnant women due to stress,
dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery.
Obesity protects against PDPH in pregnant women; increased intra-abdominal fat tissue reduced
cerebrospinal fluid leakage by increasing the pressure in the epidural space. Therefore, this
study investigated the influence of body mass index (BMI) on PDPH in elective caesarean
section patients in whom 27G spinal needles were used.

Clinical Trial – Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery

Caudal analgesia along with general anesthesia is a very popular regional technique for
prolonged postoperative analgesia in different pediatric surgical procedures where the
surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for
approximately 4-6 hours.

Recently, the use of spinal anesthesia in infants and children requiring surgeries of
sub-umbilical region is gaining considerable popularity worldwide.

– The ease of performance and the safety regarding cardio-respiratory functions makes spinal
anesthesia as an alternative to general anesthesia in infants and children undergoing
surgeries of sub-umbilical regions.

Clinical Trial – The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis

The purpose of this investigation is to determine the effects and ease of using hyperbaric
oxygen therapy HBO2 for the treatment of rheumatoid arthritis joint pain and prevention of
disease progression. In this study it is our intention to not only evaluate effects and ease
of treatment but time, cost, possible adverse events and effect size in an attempt to predict
an appropriate sample size and improve on the study design prior to a more extensive study.

Clinical Trial – Neurocryostimulation for Acute Lateral Ankle Sprain

The objective of this exploratory randomized control trial is to compare, in participants
with acute lateral ankle sprain (LAS) , the reduction of symptoms and functional limitations
between two groups of subjects who undergo a conventional rehabilitation program with
(experimental group) or without CRYOFOS (comparison group). The hypothesis is that CRYOFOS
will lead to a faster reduction of symptoms and functional limitations, and a faster return
to daily living activities.Thirty-six participants of 18 years of age and older with acute
LAS (sustained a LAS three days or less before the first evaluation session) will be
recruited and randomly assigned to either a group receiving conventional rehabilitation
program with the addition of CRYOFOS (experimental group; n=18), or to a group only receiving
the conventional rehabilitation program (comparison group; n=18). This single-blind
(evaluator), parallel-group RCT will include five evaluation sessions over 6 weeks (baseline,
day 7, week 2, week 4 and week 6) and 8 treatment sessions (1st and 2nd weeks: 3
sessions/week; 3rd and 4th weeks: 1 session/week) during a 4-week period. The primary outcome
will be the functional limitations, evaluated using the Lower Extremity Functional Scale
(LEFS).

Clinical Trial – Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section

Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids.
Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in
postpartum patients and 69% in non-pregnant patients including males and females (1). Some
researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and
effective way to reduce the incidence and severity of hypotension during cesarean section
under spinal anesthesia (2). In this new research I want to investigate the effect of slow
injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence
of itching In this double blind randomized study two hundred parturient will be randomly
allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after dilution
with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds All
parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria will
be those with allergy to any medications, contraindications to spinal anesthesia, those who
requested sedation, presence of skin lesions that may cause itching and opioid addiction.

Parturient will be monitored regarding the incidence of itching, hypotension, nausea and
vomiting. Onset and level of sensory block will also be recorded.

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