Status:
COMPLETED
EEG - Guided Anesthetic Care and Postoperative Delirium
Lead Sponsor:
Yale University
Conditions:
Delirium
Emergence Delirium
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The study is a prospective, double blinded, randomized and controlled parallel trial to investigate the effect of the anesthetic care guided by EEG monitor (SedLine) on postoperative delirium. EMODIPO...
Detailed Description
To investigate the impact of the anesthetic care guided by EEG monitor (SedLine) on (1) the incidence of delirium in post-anesthesia care unit (PACU) and within the first five days after laparoscopic ...
Eligibility Criteria
Inclusion
- Age ≥ 50 years;
- ASA Physical Score I-III
- Scheduled to undergo elective laparoscopic surgeries under general anesthesia with endotracheal intubation;
- Extubation expected after surgery;
- Scheduled to stay in hospital for \> 3 days after surgery.
Exclusion
- Refuse to participate;
- Emergent surgery;
- Trauma patients;
- Preoperative cognitive impairment characterized by Mini-Mental State Examination (MMSE) of 23 or less;
- Preoperative history of stroke, schizophrenia, major depression, Parkinson's disease, epilepsy, or dementia;
- Inability to communicate in the preoperative period due to illiteracy, language difficulties, or significant hearing or visual impairment;
- Inability to complete MMSE and delirium survey;
- Severe cardiac disease including low-output cardiac failure defined as a preoperative left ventricular ejection fraction \< 30%, or arrhythmia with pacemaker or AICD placement;
- Severe hepatic dysfunction being evaluated for liver transplantation or with a Child- Pugh Class C classification;
- Severe renal dysfunction requiring renal replacement therapy before surgery;
- Those with preoperative ASA classification of 4 or who are unlikely to survive for more than 3 days after surgery.
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2019
Estimated Enrollment :
1560 Patients enrolled
Trial Details
Trial ID
NCT03330236
Start Date
October 13 2017
End Date
September 6 2019
Last Update
November 9 2020
Active Locations (1)
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1
Xiangya Hospital
Changsha, Hunan, China, 410205