Ketofol for Preventing Postoperative Delirium in Elderly Patients

• Status: Recruiting
• Trial end date: 2021-10-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zagazig University
• Treatments: Dexmedetomidine; Ketamine; Propofol

Criteria

Inclusion Criteria:

• Patient acceptance.

• Age ≥ 60 years old.

• American society of anesthesia (ASA) (II-III).

• Gender: males &females

• BMI < 35kg/m2.

• able to communicate verbally.

• Scheduled for exploration surgery for intestinal obstruction under general anesthesia of at least 60 min duration

Exclusion Criteria:

• Patient refusal.

• Patients with delirium prior to surgery.

• Patients with drug misuse history or taking anti-psychotic drugs.

• Previous hospitalization within 3 months.

• Legal blindness, severe deafness.

• History of Acute cerebrovascular conditions; stroke or transient ischemic attack.

• Patients who could not be prepared with proper fluid resuscitation, electrolyte and acid-base correction prior to surgery.

• Patients who could be discharged from the intensive care unit (ICU) within two days.

• Patients with a known history of allergy to study drugs