CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
ketofol +2 moredrug
Likely dose
ketofol 1mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04816162
NCT04816162Phase 4Completed

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

Zagazig University·interventional·Posted Mar 25, 2021·Updated Aug 1, 2023

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 25, 2021
Enrollment StartMar 25, 2021
Primary CompletionNov 1, 2022
Study CompletionFeb 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.3 years ago

Interventions

ketofoldrug

prepared in a ratio of (1:4) respectively), where 1ml of ketamine will be added to 20 ml of propofol in a syringe pump

dexmedetomidinedrug

2 ml (200 µg) of dexmedetomidine added to 0.9% normal saline in a syringe pump

normal salineother

normal saline 0.9% in a syringe pump