EEG - Guided Anesthetic Care and Postoperative Delirium

Delirium Clinical Trial

— EMODIPOD  

Official title:

Effect of Spectral Edge Frequency and Patient State Index (Electroencephalography) - Guided Anesthetic Care on Delirium After Laparoscopic Surgery: the EMODIPOD Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330236
• Other study ID #: 201612631
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anesthesia, General
• Delirium
• Electroencephalography
• Emergence Delirium
• Laparoscopy
• Surgical Procedures, Operative

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