An interventional study of Ketamine and Dexmedetomidine in POCD - Postoperative Cognitive Dysfunction, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-04-20.
Sponsored by Tanta University · Not applicable, Interventional, and Supportive care
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Among 10 studies testing dexmedetomidine in Postoperative Cognitive Complications — 1 open to participants now, 2 under way, none of them phase 3. Dexmedetomidine · Postoperative Cognitive Complications.
Among the 10 studies testing dexmedetomidine in Postoperative Cognitive Complications, this one is the 4th largest by enrollment, is the only one that started in 2021, is one of 4 with no phase, and was the 6th registered.
260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.
Browse Postoperative Cognitive Complications studies →1 of the 10 studies testing dexmedetomidine in Postoperative Cognitive Complications is open now, in 1 country. Recruiting first, the newest first:
Chang Gung Memorial Hospital · Sites in Taiwan
Ages 60+
By country, each count listing its studies:
Dexmedetomidine: first FDA approval 1999 (PRECEDEX), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 34 Postoperative Cognitive Complications studies recruiting now, 22 (65%) set no upper age limit and 4 (12%) stop at 75 or younger; 2 take children under 18; 6 take healthy volunteers.
This study: 65 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 90 is below the median of 107 across 145 interventional studies indexed under Postoperative Cognitive Complications.
Median enrollment 90 across the 10 interventional studies. Of the 6 that completed or were terminated, 2 (33%) have results posted.
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None of the 10 has an industry lead sponsor. The 9 most frequent:
Tanta University is the lead sponsor of 1,012 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Tanta University has 1 study filed under Postoperative Cognitive Complications — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing dexmedetomidine in Postoperative Cognitive Complications, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Group II (Ketamine group). Where patients will receive ketamine in a dose of 0.3 mg/kg in physiological solution.
Group III (Dexmedetomidine group). where patients will receive dexmedetomidine in a dose of 0.5 ug/kg in a physiological solution.
-Primary outcome will be the incidence of POCD, the secondary outcomes will be the hemodynamic changes and the changes in the intraocular pressure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- The patients in this group will receive normal saline in a labeled syringe which will be prepared by an assistant nurse not participating in the study.
Drug: Normal saline
- The patients in this group will receive ketamine at a dose of 0.3 mg/kg dissolved in normal saline in a labeled syringe which will be prepared by an assistant nurse not participating in the study.
Drug: Ketamine
- The patients in this group will receive Dexmedetomidine in a dose of 0.5 ug/kg dissolved in normal saline in a labeled syringe which will be prepared by an assistant nurse not participating in the study.
Drug: Dexmedetomidine
Ketamine at a dose of 0.3 mg/kg dissolved in normal saline.
Dexmedetomidine at a dose of 0.5 ug/kg dissolved in normal saline.
Normal saline in a labeled syringe
The postoperative cognitive function
Short Portable Mental Status Questionnaire (SPMSQ) It is a score system that depends upon the number of errors in 10 questions asked to the patient where; - 0-2 errors: normal mental functioning 3-4 errors: mild cognitive impairment 5-7 errors: moderate cognitive impairment 8 or more errors: severe cognitive impairment Mental Status Questionnaire (SPMSQ) score will be used to assess the cognitive dysfunction
Time frame: Within the first 3 days after surgery
Change in the intraocular pressure
The IOP will be measured before the peribulbar anesthesia, min, 5 min and 10 min after peribulbar injection, then immediately after surgery.
Time frame: Throughout the whole intraoperative period
Plan to share: Yes — The data of the primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: till 6 months after approval of the publication of the trial.
Access criteria: Contact the principle investigator
No publications or documents are linked to this record.
Ran from Feb 2021 to primary completion in Apr 2021, 2 months.
Of 63 non-industry interventional studies with no phase under Postoperative Cognitive Complications, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's 2 months is below that.
Counting every sponsor, half of 63 studies reached it within 16 months; a quarter within 8 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ketamine · Dexmedetomidine
Postoperative Cognitive Complications →