Manual vs Automated Anesthesia : Impact On The Incidence Of POCD

NCT03148730 | Completed DMC

• 1 other identifier: P2015/539 / B406201526591
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be the first study to report the combined use of three independent closed-loop systems together to assist clinicians in titrating anesthesia, analgesia, fluid and optimize ventilation in frailty old patients undergoing moderate to high risk surgery. The potential benefits of optimizing the control of these variables by advanced closed loop systems are two-fold. Firstly, this will likely decrease the variance of delivered care and reduce deviation from the established standards, resulting in improved post operative cognitive outcomes in elderly patients. Secondly, this would establish a precedent that automated intraoperative systems have strong clinical significance and are more than "complicated toys", which is unfortunately how they are perceived now. Hypothesis: Automated control of anesthetic depth (minimal episodes of overly deep or light anesthesia) and hemodynamics (via improved volume administration) can decrease the occurrence of postoperative cognitive dysfunction in elderly patients undergoing moderate to high risk surgery (Better MOCA test in the postoperative period compared to the manual group \[+ two points in average\])

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative cognitive dysfunction (POCD)

  assessment of the POCD using the MOCA test ( done by a psychiatrist and a psychologist). This will be done preoperatively, at postoperative day 3-5 for moderate risk surgery and postoperative day 7-10 for high risk surgery

  first month

Secondary Outcomes (19)

• Assesment of the incidence of POCD using different others tests:

  Before Surgery

• Assesment of the incidence of POCD using different others tests:

  day 5 after surgery

• Assesment of the incidence of POCD using different others tests:

  day 10 after surgery

• Long term incidence of POCD

  month 3 post surgery

• Assessment of the Quality of life EQ-5D-5L

  3 months

Study Arms (2)

manual group

NO INTERVENTION

This group will have a standard of care anesthesia. All the drugs, fluid and adjustement of ventilation settings will be done manually by the supervising anesthesiologist using the same drugs and fluids as the closed-loop group

automated closed-loop group

EXPERIMENTAL

This group will have a fully automated anesthesia, analgesia , ventilation and fluid management using 3 indenpendent closed-loop systems same drugs used in both groups ( propofol and remifentanil, Plasmalyte and /or Voluven)

Device: closed-loop group

Interventions

closed-loop group DEVICE

Use of 3 indenpendent closed-loop systems to deliver the propofol, remifentanil, fluid and to adjust ventilation

automated closed-loop group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients \> or equal 60 years old
• ASA score I-III
• Scheduled for non cardiac surgery under total intravenous anesthesia
• Self sufficient (living at home or in non medical institution)
• MOCA test preop \> 23/30
• No Stroke, alzeihmer, Parkinson disease
• Written informed consent signed

You may not qualify if:

• Allergy to propofol or remifentanil
• MOCA test \< 23/30
• Visual or hearing deficiency
• Atrial fibrillation, or other Contra indication to the use of dynamic parameters of fluid responsiveness.
• Chronic renal failure ( creatinin level maximum at 2 mg/ml; no dialysis)
• Large liver resection : our center has a strict fluid /CVP fluid restriction in place

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Alexandre Joosten, M.D

  Erasme

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: single blinded ( outcome assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 groups one = manually conducted anesthesia second = fully automated anesthesia, analgesia, ventilation and fluid management

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 11, 2017
• Study Start: May 10, 2017
• Primary Completion: November 21, 2017
• Study Completion: November 21, 2017
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

BE (1)