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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03330236
Other study ID # 201612631
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2017
Est. completion date September 6, 2019

Study information

Verified date November 2020
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. EMODIPOD = Electroencephalography Monitoring tO Decrease the Incidence of PostOperative Delirium


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 surgery and (2) the incidence of in-hospital complications and 30-day mortality in adult patients after laparoscopic surgery.


Recruitment information / eligibility

Status Completed
Enrollment 1560
Est. completion date September 6, 2019
Est. primary completion date September 5, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: 1. Age = 50 years; 2. ASA Physical Score I-III 3. Scheduled to undergo elective laparoscopic surgeries under general anesthesia with endotracheal intubation; 4. Extubation expected after surgery; 5. Scheduled to stay in hospital for > 3 days after surgery. Exclusion Criteria: 1. Refuse to participate; 2. Emergent surgery; 3. Trauma patients; 4. Preoperative cognitive impairment characterized by Mini-Mental State Examination (MMSE) of 23 or less; 5. Preoperative history of stroke, schizophrenia, major depression, Parkinson's disease, epilepsy, or dementia; 6. Inability to communicate in the preoperative period due to illiteracy, language difficulties, or significant hearing or visual impairment; 7. Inability to complete MMSE and delirium survey; 8. Severe cardiac disease including low-output cardiac failure defined as a preoperative left ventricular ejection fraction < 30%, or arrhythmia with pacemaker or AICD placement; 9. Severe hepatic dysfunction being evaluated for liver transplantation or with a Child- Pugh Class C classification; 10. Severe renal dysfunction requiring renal replacement therapy before surgery; 11. Those with preoperative ASA classification of 4 or who are unlikely to survive for more than 3 days after surgery.

Study Design


Intervention

Device:
Anesthetic "depth" management
The propofol and remifentanil infusion rates will be adjusted to maintain the spectral edge frequency (SEF) value at 10-15 and the patient state index (PSI) value at 25-50 based on the SedLine EEG Brain Function Monitoring.

Locations

Country Name City State
China Xiangya Hospital Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other NRS Pain Score Numeric Rating Scale subjective pain where 0 indicates no pain and 10 indicates the worst pain. 24 hours after surgery
Other NRS Sleep Score Numeric Rating Scale subjective sleep quality at 8:00 am where 0 indicates best possible sleep and 10 indicates worst possible sleep 24 hours after surgery
Primary Number of Participants With Postoperative Delirium The Number of Participants with Postoperative Delirium is operationally defined as the count of patients with postoperative delirium. Postoperative delirium is an acute brain dysfunction characterized by inattention, disorganized thinking, and a fluctuating course. up to five (5) days after surgery
Secondary Emergence Delirium Incidence (count) of emergence delirium at post-anesthesia care unit (PACU) 30 min following the extubation
Secondary Non-delirium Complications Complications after surgery such as acute kidney injury, cardiac events, cerebrovascular events, renal injury, GI complications, infections (etc) were assessed using the Clavien-Dindo classification. Reported are the count of those with a composite complication Clavien-Dindo Grade =II.
The classifications are as follows:
Grade I = Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.
Grade II = Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included.
Grade III = Requiring surgical, endoscopic or radiological intervention; IIIa = Intervention not under general anesthesia; IIIb = Intervention under general anesthesia.
Grade IV = Life-threatening complication (including CNS complications)* requiring IC/ICU-management; IVa = single organ dysfunction (including dialysis); IVb
within 30 days after surgery
Secondary GI Functional Recovery Speed of GI functional recovery (pass gas) within 30 days after surgery
Secondary All-cause 30-day Mortality All-cause 30-day mortality 30 days after surgery
Secondary Length of Hospital Stay Length of hospital stay was counted from the day of surgery (day 0) to the day when the patient was ready for discharge. up to 30 days after surgery
Secondary ICU Admission Count of patients that were admitted to ICU after surgery. up to 72 hours
Secondary Length of ICU Stay the duration of time when the patient residing in ICU up to 30 days after surgery
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