Optimized Anesthesia to Reduce Incidence of Postoperative Delirium

Study Overview
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Brief Summary
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The purpose of this study is to compare the difference of incidence of postoperative delirium between patients received general anesthesia guided by Bispectral index (BIS) and patients received general anesthesia using standard technique.

Detailed Description
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General anesthesia is one of precipitating factor of postoperative delirium which Its mechanism is still unknown. General anesthesia can affect on pattern of electroencephalograph. Previous studies showed that patients received BIS guided anesthesia could wake up faster, earlier extubation and stay in recovery room shorter compared to standard general anesthesia. Optimized level of anesthesia by BIS could reduce cognitive dysfunction in elderly patients and reduce biological marker of brain injury. Therefore, the investigators hypothesized that adjustment of general anesthesia by BIS guided could protect central nervous system and reduce incidence of postoperative delirium.

Official Title
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Optimized Anesthesia to Reduce Incidence of Postoperative Delirium in Elderly Undergoing Elective, Non-cardiac Surgery: a Randomized Controlled Trial (POD-II)

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Device: Bispectral index, as measured by a BIS processor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age equal or more than 65 years. Patients undergoing general anesthesia. Patients undergoing scheduled, non-cardiac surgery Exclusion Criteria: Patients undergoing neurosurgery. Patients cannot understand Thai language. Patients who have severe visual or hearing impairment.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bispectral index (BIS) group<br>Bispectral index as measured by a BIS Processor is used to guide doses of anesthetic for maintaining the BIS values of 40-60 | Device: Bispectral index, as measured by a BIS processor<br>* Comparisons of incidence of postoperative delirium.<br>* Other names: BIS PROCESSOR, MODEL QE-910P, NIHON KOHDEN CORPORATION;|
| No Intervention: Control group<br>Clinical signs is used to guide doses of anestheitics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients have postoperative delirium | Assess postoperative delirium by using Confusion Assessment Method for intensive care unit (CAM-ICU) at recovery room and Confusion Assessment Method at inpatient ward. | Participants will be followed during the duration of hospital stay, an expected avarage of two weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with impaired cognitive function | Assessed postoperative cognitive function by using Mini-Mental State Examination and Montreal Cognitive Assessment (MoCA) . | Up to 6 months | 
| Time to recovery | Time between end of anesthesia and eye opening, spontaneous breathing, and extubation. | The end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative delirium