Anesthesia, General, Delirium, Electroencephalography, Emergence Delirium, Laparoscopy, Surgical Procedures, Operative
Conditions
Keywords
Electroencephalography, Spectral edge frequency, Patient state index, Anesthesia, Laparoscopic surgery, Postoperative delirium, Emergence delirium
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. EMODIPOD = Electroencephalography Monitoring tO Decrease the Incidence of PostOperative Delirium
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 surgery and (2) the incidence of in-hospital complications and 30-day mortality in adult patients after laparoscopic surgery.
Interventions
DEVICEAnesthetic 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.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Patients, care providers (excluding the anesthesia team taking care of the patient in the operative room), and outcome assessors are blinded to the results of randomization or group assignment.
Intervention model description
The study is a prospective, pragmatic, patient and outcome assessor blinded, randomized 1:1 and controlled parallel trial.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Delirium | up to five (5) days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergence Delirium | 30 min following the extubation | Incidence (count) of emergence delirium at post-anesthesia care unit (PACU) |
| Non-delirium Complications | within 30 days after surgery | 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 |
| GI Functional Recovery | within 30 days after surgery | Speed of GI functional recovery (pass gas) |
| All-cause 30-day Mortality | 30 days after surgery | All-cause 30-day mortality |
| ICU Admission | up to 72 hours | Count of patients that were admitted to ICU after surgery. |
| Length of ICU Stay | up to 30 days after surgery | the duration of time when the patient residing in ICU |
| Length of Hospital Stay | up to 30 days after surgery | Length of hospital stay was counted from the day of surgery (day 0) to the day when the patient was ready for discharge. |
Other
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain Score | 24 hours after surgery | Numeric Rating Scale subjective pain where 0 indicates no pain and 10 indicates the worst pain. |
| NRS Sleep Score | 24 hours after surgery | Numeric Rating Scale subjective sleep quality at 8:00 am where 0 indicates best possible sleep and 10 indicates worst possible sleep |
Countries
China
Participant flow
Recruitment details
Among the 70,783 patients scheduled to undergo an elective surgical procedure in the main operating rooms at Xiangya Hospital from October 2017 to August 2019, a total of 1,560 participated in this study.
Participants by arm
| Arm | Count |
|---|---|
| EEG Guided All patients in the EEG Guided study arm will receive the anesthetic care guided by the SedLine EEG Brain Function Monitor in addition to the conventional monitors. In addition to the conventional/standard interventions of anesthetic care, an additional intervention related to this trial is the anesthetic depth management via the titration of the propofol and remifentanil infusion rates to maintain SEF and PSI in the targeted ranges based on the SedLine EEG monitoring.
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. | 773 |
| Usual Care All patients in the usual care arm (control) will receive the anesthetic care guided by the conventional monitors only. Patients in the control arm will be monitored using the SedLine EEG Brain Function Monitor; however, the screen of this monitor will be covered by an opaque cloth and blinded to the anesthesia team. | 774 |
| Total | 1,547 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 4 | 3 |
| Overall Study | SedLine malfunction/blinding | 19 | 14 |
| Overall Study | Surgery aborted/converted to open | 60 | 52 |
| Overall Study | Volatile anesthetics used | 11 | 8 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | EEG Guided | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 62 years | 61 years | 61 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 773 Participants | 1547 Participants | 774 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 773 participants | 1547 participants | 774 participants |
| Sex: Female, Male Female | 335 Participants | 650 Participants | 315 Participants |
| Sex: Female, Male Male | 438 Participants | 897 Participants | 459 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 779 | 1 / 781 |
| other Total, other adverse events | 3 / 779 | 3 / 781 |
| serious Total, serious adverse events | 0 / 779 | 0 / 781 |
Outcome results
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.
Time frame: up to five (5) days after surgery
Population: Modified ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EEG Guided | Number of Participants With Postoperative Delirium | 8 Participants |
| Usual Care | Number of Participants With Postoperative Delirium | 9 Participants |
Secondary
All-cause 30-day Mortality
All-cause 30-day mortality
Time frame: 30 days after surgery
Population: Modified ITT population/patients with complete data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EEG Guided | All-cause 30-day Mortality | 2 Participants |
| Usual Care | All-cause 30-day Mortality | 1 Participants |
Secondary
Emergence Delirium
Incidence (count) of emergence delirium at post-anesthesia care unit (PACU)
Time frame: 30 min following the extubation
Population: Modified ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EEG Guided | Emergence Delirium | 91 Participants |
| Usual Care | Emergence Delirium | 102 Participants |
Secondary
GI Functional Recovery
Speed of GI functional recovery (pass gas)
Time frame: within 30 days after surgery
Population: These data were not collected and analyzed.
Secondary
ICU Admission
Count of patients that were admitted to ICU after surgery.
Time frame: up to 72 hours
Population: Modified ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EEG Guided | ICU Admission | 17 Participants |
| Usual Care | ICU Admission | 15 Participants |
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.
Time frame: up to 30 days after surgery
Population: Modified ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EEG Guided | Length of Hospital Stay | 6 days |
| Usual Care | Length of Hospital Stay | 6 days |
Secondary
Length of ICU Stay
the duration of time when the patient residing in ICU
Time frame: up to 30 days after surgery
Population: These data were not collected and analyzed.
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
Time frame: within 30 days after surgery
Population: Modified ITT population/patients with valid data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EEG Guided | Non-delirium Complications | 175 Participants |
| Usual Care | Non-delirium Complications | 193 Participants |
Other Pre-specified
NRS Pain Score
Numeric Rating Scale subjective pain where 0 indicates no pain and 10 indicates the worst pain.
Time frame: 24 hours after surgery
Population: These data were not collected and analyzed.
Other Pre-specified
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
Time frame: 24 hours after surgery
Population: These data were not collected and analyzed.