Status:
COMPLETED
Impact Dexmedetomidine on Postoperative Delirium in Patients 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 one of the most common serious complications after major surgery and is associated with undesirable consequences. Prevention of postoperative delirium is recommended in the c...
Detailed Description
Postoperative delirium is one of the most common serious complications after major surgery and is associated with undesirable consequences. Prevention of postoperative delirium is recommended in the c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- age under 18 years;
- 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 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 defined as Child-Pugh class C;
- severe renal dysfunction requiring renal replacement therapy before the surgery;
- allergies to ingredients or components of dexmedetomidine hydrochloride;
- American Society of Anesthesiologists classification of IV to VI;
- moribund condition with low likelihood of survival for more than 24 hours;
- pregnancy or lactation women;
- current enrollment in another clinical trial;
- refusal to participate.
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04494828
Start Date
August 10 2020
End Date
December 21 2020
Last Update
January 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050