drugset / Trial / NCT04816162

Ketofol for Preventing Postoperative Delirium in Elderly Patients

NCT04816162 ↗

Phase 4 Completed 120 enrolled Zagazig University
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2021-03-25
Primary completion
2022-11-01
Completion
2023-02-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 200 ug Intravenous
Comparator Ketamine Small molecule 1 ml Intravenous
Comparator Propofol Small molecule 20 ml Intravenous

Indications