Automated Administration of Intravenous Compared With Inhalatory Anesthesia on the Occurrence of Postoperative Delirium

Study Overview
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Brief Summary
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The intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of postoperative delirium, compared with an inhalational anesthesia.

Detailed Description
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Scientific background Postoperative delirium (POD) is a common complication occurring in 5 to 50 % of elderly patients following an operation. Delirium is a serious complication leading to many medical as well as social and economical consequences. Several studies suggest that, both, the choice of anesthetic agents and the conduction of anesthesia might decrease the incidence of POD. Objectives Study goal and primary aim: the intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of POD, compared with an inhalational anesthesia. The primary aim of the present study (i.e. incidence of POD) will be assessed by the Nursing Delirium Screening Scale (NDSS). Secondary aims: Secondary aim 1: Assessment of a potential difference on the incidence of PONV between the 2 groups of patients (i.e. intravenous vs. inhaled) by comparison of the number of episodes of nausea and vomiting and the need to treat this complications, between both groups. Secondary aim 2: study if the difference of in the impairment of cognitive function might be correlated either with the type of drugs used to conduct anesthesia or with the control the index of cerebral activity (i.e. the BIS). The respective influences of the control of the index of cerebral activity (i.e. the BIS) and of the anesthetic drugs on the occurrence of postoperative cognitive dysfunctions (POCD) will be assessed by comparing cognitive function tests on matched groups on the percentage of time spent in different ranges of values of the cortical index Population of patients Patients of 60 years old or more, having given their written informed consent and who should undergo a surgical procedure of at least one hour. Inclusion criterion Patients will be included in the study if: They are 60 years old or older, They have given their written informed consent, They have to undergo a surgical procedure of one hour or longer. Non-inclusion criterion Following patients will non be eligible for the current study: Pregnant women, Patients presenting a contra-indication to the monitoring of cerebral activity (i.e. intracranial surgery, neuroleptic or anti epileptic medications, pace maker), Patients presenting any allergy to propofol and or remifentanil, Patients under guardianship. Experimental protocol Information and inclusion of patients during the preoperative anesthetic assessment consultation First assessment of the NDSS at patient arrival in the operating room Randomization prior to the induction on the anesthesia Second NDSS just before patient leaving of PACU Recording of all PONV event as well as any administration of anti emetic drug Number of subjects: 1000 Number of center: 4 Duration of the research: 36 months Statistical Analysis: Sequential group analysis. The preoperative and postoperative NDSS test will be analyzed with an ANOVA for repeated-measure and multiple-comparison. The main criterion will be analyzed with a Kaplan-Meier survival analysis on the global data and with a Cox regression that will take into account the qualitative factors represented by the type of anesthesia Description of the Nursing Delirium Screening Scale (NDSS) that is a validated scale to assess POD at the bedside. Five areas are assessed: disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation Description A screening tool designed for nurses to use at the end of their shift to identify patients with delirium, derived from the Confusion Rating Scale (CRS). Raters reference behaviors that they have witnessed in the patient or that the patient'snurse has witnessed during their shift to score the NDSS. The NDSS can be rated one or more times daily. Scoring information Each feature is scored on 0-2 based on severity, with 0=absent, 1=mild, and 2=severe. Positive NDSS is score ≥ 2, maximum total score is 10.

Official Title
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Impact of the Automated Administration of Intravenous Anesthesia Compared to Inhalatory Anesthesia on the Speed of Emergence and the Occurrence of Postoperative Delirium

Conditions
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Postoperative Delirium, Elderly Patient, General Anesthetic Drug Adverse Reaction

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane
* Drug: Remifentanil automatic
* Drug: Remifentanil manual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 59 year Informed written consent before enrolment; Procedure duration > 60 min. Speaking French Possible contact one-month following surgery Exclusion Criteria: Contraindication of brain monitoring (intracranial surgery), pace-maker. Propofol or remifentanil allergy. Patients under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous group<br>Propofol & remifentanil administration using the closed-loop controller with the Easy-TIVA platfrom. | Drug: Propofol<br>* Propofol will be automatically administered according to the EasyTIVA device algorythm to maintain the BIS value within the 40-60 interval<br>Drug: Remifentanil automatic<br>* Remifentanil will be automatically administered according to the EasyTIVA device algorythm to maintain the BIS value within the 40-60 interval<br>|
| Active Comparator: volatile anesthesia group<br>Sevoflurane will be administered manually according to the BIS values. Remifentanil will be administered manually using a Target Controlled Infusion pump using the Minto model. | Drug: Sevoflurane<br>* Sevoflurane will be manually administered to maintain the BIS value within the 40-60 interval<br>Drug: Remifentanil manual<br>* Remifentanil will be manually administered to maintain the BIS value within the 40-60 interval<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the Nurse Delirium Screening Scale in the early postoperative period between intravenous vs halogenated general anesthesia | occurrence of POD as measured by the Nursing Delirium Screening Scale The Nursing Delirium Scale Symptom Symptom rating Disorientation 0 points 1 point 2 points Inappropriate behavior 0 points 1 point 2 points Inappropriate communication 0 points 1 point 2 points Illusion/hallucination 0 points 1 point 2 points Psychomotot retardation 0 points 1 point 2 points Total score ≤ 2 points > 2 points Delirium No Yes | Measure of the Nurse Delirium Screening Scale, up to an estimated maximum of 3 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia, general, postoperative delirium, postoperative nausea and vomiting, elderly, total intravenous anesthesia, closed-loop anesthesia, EEG monitoring, propofol, remifentanil, sevoflurane