Ketofol vs Dexmedetomidine for Preventing Post-operative Delirium in Elderly Patients Undergoing Intestinal Obstruction Surgeries. A Randomized Controlled Study

6704/10-3-2021

* 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.

2021-03-25

2022-11-01

2023-02-01

Completed

Early phase I

120

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A computer-generated table will be used to divide patients equally into three study groups\n\n* In group C (control group):21 ml of normal saline 0.9% will be I.V infused at a rate of 0.3-0.4 mg/kg/h to the patient.\n* In group K: ketofol (a mixture of ketamine and propofol will be prepared in a ratio of (1:4) respectively), will be I.V infused at a rate of 0.3-0.4 mg/kg/h to the patient.\n* In group D: adding dexmedetomidine 2 ml (200 µg) to 19 ml of 0.9% normal saline to start I.V infusion to the patient', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'double-blinded(participants and outcome assessors)', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

2023-08-01