At a glance
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Ketofol vs Dexmedetomidine for Preventing Post-operative Delirium in Elderly Patients Undergoing Intestinal Obstruction Surgeries. A Randomized Controlled Study
In Brief
A Phase 4 clinical trial evaluating ketofol, dexmedetomidine, and 1 other intervention for Delirium on Emergence. Completed, enrolled 120 participants across 1 site.
Detailed Summary
* Delirium is a cognitive disturbance characterized by acute and fluctuating impairment in attention and awareness. Although its incidence in the general surgical population is 2-3%, it has been reported to occur in up to 10-80% of high-risk patient groups. In addition, the occurrence of postoperative delirium is associated with considerably raised morbidity and mortality and increased healthcare resource expenditure. * In the general patient population, no prophylactic pharmacologic treatment has shown widespread effectiveness in preventing delirium. Several studies have failed to find a magic pharmacologic bullet for preventing delirium-ketamine, haloperidol, propofol, antipsychotic and benzodiazepine drugs have recently tested without a clear result of its effectiveness. * Dexmedetomidine is an attractive pharmacologic option because of its biological plausibility in modifying several known contributors to delirium. * Up to investigators' knowledge, there is no study done to compare the effect of infusion of dexmedetomidine and ketofol mixture as prophylactic agents for high-risk patients as elderly patients who undergoing high-risk surgery such as intestinal obstruction surgery against postoperative delirium occurrence.
Study Details
Timeline
Interventions
prepared in a ratio of (1:4) respectively), where 1ml of ketamine will be added to 20 ml of propofol in a syringe pump
2 ml (200 µg) of dexmedetomidine added to 0.9% normal saline in a syringe pump
normal saline 0.9% in a syringe pump