Clinical Trials

Clinical Trial – The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds

In Ontario, wound care support has steadily increased over the years. With the growth of the
aging population, the financial and psychological burden related to wound care will continue
to rise. Studies have shown that structured meditation programs can improve on the recovery
process for both physical and psychological disease. Therapeutic treatments like Hyperbaric
Oxygen Therapy (HBOT) for chronic wounds have shown to promote angiogenesis, cerebral blood
and neuroplasticity in patients with stroke, traumatic brain injury and chronic pain. By
combining meditation and HBOT, this have been independently shown to improve healing and
reducing costs associated with chronic wounds.

Clinical Trial – Feasibility and Efficacy of Enhanced Recovery After Surgery (ERAS) on Length of Stay Among Laparotomy Patients at Mbarara Regional Referral Hospital

The main goal of ERAS is to enhance the recovery of patients, and this has secondary effects,
such reduced length of hospital stay, minimal postoperative complications and lessen
readmission rates. ERAS protocols have been shown to be feasible and safe across the world.
Although it has been shown to be effective in the developed settings and can potentially
reduce the length of hospital stay, and the cost of healthcare in the perioperative period.
The multimodal program of ERAS has been less implemented in the low and middle income African
countries. Studies done outside Uganda (Egypt and South Africa) have demonstrated that ERAS
program can be feasible and yields favorable outcomes in patients.

Clinical Trial – Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:

Diabetic foot ulcers are associated with high risk of amputation. About 50% of patients
undergoing non-traumatic lower limb amputations are diabetics5. The 5-year amputation rate is
estimated to be 19% with a mean time to amputation 58 months since the onset of an diabetic
foot ulcer6.Because infection and tissue hypoxia are the major contributing factors for
non-healing diabetic foot ulcers, hyperbaric oxygen therapy (HBO) carries a potential benefit
for treating these problematic wounds that do not respond to standard therapy.

The role of oxygen in the wound healing cascade and subsequent combatting action against
bacterial invasion, especially anaerobes, is well documented.14 Delayed or arrested healing
and the development of infection is a direct result from decreased perfusion and poor
oxygenation of tissue.15 The presence of wound hypoxia is an major etiological pathway in the
development of chronic non-healing diabetic foot ulcers

Clinical Trial – ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients

As people age, the incidence of prostate hyperplasia increases. So patients under
Transurethral Resection of Prostate(TURP) or Holmium Laser Ennucleation of Prostate(HoLEP)
are mostly ole age people. Most old age patient has several underlying disease. So patients
can develop high mortality and morbidity. Most surgeries for Prostate Resection are taken
under Spinal anesthesia. Adequate block level for Prostate Resection is T10. But sometimes,
old age patients can develop severe complication after spinal anesthesia. So we started this
study to know the adequate drug concentration for Spinal anesthesia taken for Prostate
Resection surgery.

Clinical Trial – Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery.

Prilocaine is a local anesthetic drug which as an intermediate duration of action shorter
than bupivacaine 0,5% that is usually used for spinal anesthesia in scheduled cesarean
section. No study has yet investigated the use of hyperbaric (HB) prilocaine 2% for
intrathecal anesthesia in cesarean section. The aim of this study is to determine the
Effective Dose (ED) 95 of hyperbaric (HB) prilocaine 2% by using the Continual Reassessment
Method (CRM)

Clinical Trial – Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal Hyperbaric Prilocaine.

The prilocaine is a very common local anesthetic that has the disadvantage of being
metabolized to o-toluidine, a human carcinogen.

Hyperbaric 2% prilocaine (HP), recently developped, is increasingly used for spinal
anesthesia in ambulatory surgery. But the formation of carcinogenic metabolites induced by
the hyperbaric prilocaine is not yet known. The aim of this study is to investigate whether
the intrathecal administration of 50 mg hyperbaric prilocaine induces also the formation of
carcinogenic complexes such as urinary o-toluidine and hemoglobin adducts from o-toluidine in
blood.

Clinical Trial – Correlation Between VCL, AC and Spread of Intrathecal Hyperbaric Bupivacaine in the Term Parturient

Currently there is no guideline to decide on the most appropriate dose of spinal anaesthesia.
This study is planned to find out factors that influence the effect of spinal anaesthesia in
pregnant mother going for Caesarean section and both the mother and baby’s outcomes.
Investigators will recruit pregnant mothers who are planned for elective Caesarean section
under spinal anaesthesia at University Malaya Medical Centre before operation and obtained
their consent to participate in this study. Routine standard care will be provided for all
the participants. Perioperative data including vertebral column length and abdominal girth
measured by measuring tape will be collected and analysed. There is no new intervention
performed on participants.

Clinical Trial – Intrathecal Neostigmine for Prevention of PDPH

Neuraxial blocks continue to be the cornerstone of anesthesia and postoperative analgesia for
normal vaginal delivery and elective caesarean section due to its approved safety and
efficiency for decades. Post-dural puncture headache (PDPH) is still one of the most common
complications of neuraxial anesthetic techniques. The headache could be severe and limit the
activities of the new mother to care for her baby, prolong hospital stay.

PDPH is defined as a headache that develops within five days of dural puncture and can’t be
attributed to any other types of headache and mostly is postural in character.

Neostigmine methylsulfate is a synthetic carbamic acid ester which reversibly inhibits the
enzyme Acetylcholine esterase (AChE) that makes more Acetylcholine molecules available at
cholinergic receptors. Neostigmine is used in anesthesia mainly as a reversal for
non-depolarizing neuromuscular agents.

Intrathecal (IT) neostigmine was tried as an adjuvant to local anesthetics in IT block for
elective cesarean sections to decrease local anesthetic consumption and to prolong
postoperative analgesia. Side effects of IT neostigmine are dose-dependent with doses more
than 25 µg especially nausea and vomiting and could be decreased by increasing the baricities
of the local anesthetic solutions and by early head up position after IT injection. However,
its effect on PDPH was not investigated before in literature.

Parturients will be randomly assigned into one of two groups: the intervention group will
receive 20 µg with IT Bupivacaine and the control group will receive an equivalent volume of
dextrose 5% with the IT Bupivacaine.

The objective of the current study is to evaluate the efficacy and safety of IT neostigmine
as an adjuvant to bupivacaine in reducing the incidence and severity of post-dural puncture
headache in parturients scheduled for an elective cesarean section.

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