Last reviewed · How we verify
NCT04134052: ketaminvsMDZ
Ketamine vs Midazolam on Cognitive Function in Elderly in Elective Surgery Three-Months Postoperatively (ketaminvsMDZ)
Phase 3 trial testing ketamine sedation versus midazolam sedation in Cognitive Dysfunction in 68 participants. Status unknown.
15 May 2021
Quick facts
| Lead sponsor | Universidad de Colima |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 68 |
| Start date | 24 January 2021 |
| Primary completion | 15 May 2021 |
| Estimated completion | 20 June 2021 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- ketamine sedation versus midazolam sedation — full drug profile →
Conditions studied
- Cognitive Dysfunction — all drugs for Cognitive Dysfunction →
Sponsor
Universidad de Colima — full company profile →
Who can join
Adults 60 to 85, any sex, with Cognitive Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Deterioration of posoperative cognitive function (DCPO) is an intermediate state between normal cognitive aging and dementia, defined as a cognitive alteration greater than expected for the patient's age and educational level, but which doesn't interfere with the activities of daily life, in its evolution it can lead to dementia or it can present reversal of the deterioration with return to a normal cognitive state, or a stabilization with permanence in a state of moderate alteration. In general, higher cognitive function can be affected by organic or functional problems, anesthetic-surgical, diseases associated with the elderly and / or chronic-degenerative comorbidities. Older patients who undergo regional anesthesia have special interest, the adverse cardiovascular effects, or prolonged sedation due to a pharmacokinetics that is altered by age, call special attention to reduce complications in the postoperative period. In 2010 at the Siglo XXI Hospital in Mexico City, the 68-year-old population attended was 30% of those with postoperative cognitive dysfunction 26% a week, and 10% persistence at 3 months. The DSM V recommends a neuropsychiatric, psychological and cognitive evaluation of the patient in the postoperative period, through tests such as the Mini Mental State Examination. sub-anesthetic doses of ketamine have been recently proposed to reduce the postoperative markers of inflammation, pain and opioids, in addition to having an antidepressant effect. There is a pharmacological rationale for using ketamine as a preventative measure against postoperative delirium based on its N-methyl-D-aspartate (NMDA) antagonism, It has the potential to protect against such neurological injury.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04134052
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cognitive Dysfunction
Currently open trials in the same condition.
- NCT07526740 — Brain Stimulation and Cognitive Training for MCI · NA · recruiting
- NCT07517237 — taVNS + CCT for Neurocognitive Rehab · NA · recruiting
- NCT07171450 — Cognitive Remediation · NA · recruiting
- NCT07418008 — The Liver Cirrhosis Cognitive Decline Scale (LiCCoS) · recruiting
- NCT07394504 — Effects of Turning Based Dual Task Training on Balance and Mild Cognitive Impairment in Diabetic Peripheral Neuropathy · NA · recruiting
Other Universidad de Colima trials
Trials by the same sponsor.
- NCT07397702 — Effects of HIIT and MICT Training on Cardiorespiratory Fitness, Testosterone/Cortisol Ratio, and Mental Health in Young · NA · not yet recruiting
- NCT06268964 — Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics · Phase 1, PHASE2 · recruiting
- NCT06195436 — Efficacy of Acceptance and Commitment Therapy on Serum GDF-15 Levels in Older Adults With and Without Depression: a Non- · NA · unknown
- NCT05808270 — Nutrition Care Process in Mexican Older Adults · NA · unknown
- NCT07489924 — Microbiological Effect of 0.12% Chlorhexidine Digluconate and 0.05% Cetylpyridinium Chloride vs Probiotics (Lactobacillu · Phase 4 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04134052 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad de Colima
- Last refreshed: 26 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04134052.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing