Status:
UNKNOWN
Dexmedetomidine for Prevention of Postoperative Delirium After Intracranial Operation for Brain Tumor
Lead Sponsor:
Capital Medical University
Conditions:
Central Nervous System Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Postoperative delirium is common after major surgery, and is associated with adverse outcomes. Systematic reviews and meta-analyses of randomized controlled trials have shown that perioperative admini...
Detailed Description
Postoperative delirium is common after major surgery, and is associated with adverse outcomes. However, patients with neurological illness are usually excluded from previous researches. Recently, limi...
Eligibility Criteria
Inclusion
- The inclusion criteria are adult patients after elective intracranial operation for brain tumor under general anesthesia and who are admitted to the ICU directly from the operating room or postoperative care unit.
- The exclusion criteria include:
- Admitted to the ICU after 22:00 PM;
- Medical records documented preoperative history of mental or cognitive disorders including schizophrenia, epilepsy, Parkinsonism, or dementia;
- Medical records documented inability to communicate in the preoperative period due to coma or language barrier;
- History of drug abuse of psychoactive and anesthetic drugs;
- Known preoperative severe sinus bradycardia (lower than 50 beats/min), sick sinus syndrome, second- or third-degree atrioventricular block, or left ventricular ejection fraction lower than 30%;
- Serious hepatic dysfunction (Child-Pugh class C);
- Severe renal dysfunction requiring renal replacement therapy before the surgery;
- Allergies to ingredients or components of 5-\[(1S)-1-(2,3-dimethylphenyl)ethyl\]-1H-imidazole (dexmedetomidine hydrochloride);
- American Society of Anesthesiologists (ASA) classification of IV to VI;
- Moribund condition with low likelihood of survival for more than 24 hours;
- Pregnancy or lactation women;
- Current enrolment in another clinical trial;
- Refuse to participate.
Exclusion
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04399343
Start Date
March 1 2021
End Date
October 1 2021
Last Update
January 28 2021
Active Locations (1)
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1
Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070