Dexmedetomidine for Prevention of Postoperative Delirium After Intracranial Operation for Brain Tumor (DEPOD)
Central Nervous System Diseases
About this trial
This is an interventional prevention trial for Central Nervous System Diseases focused on measuring dexmedetomidine, delirium, postoperative, intracranial operation, prevention
Eligibility Criteria
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.
Sites / Locations
- Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Dexmedetomidine group
Normal saline group
Continuously intravenous infusion of dexmedetomidine hydrochloride at a rate of 0.1 μg/kg/hour (0.025 ml/kg/hour) started immediately after enrollment until 08:00 AM on the postoperative day one.
Continuously intravenous infusion of normal saline at a rate of 0.025 ml/kg/hour started immediately after enrollment until 08:00 AM on the postoperative day one.