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Halted due to COVID 19; we believe we have adequate data for analysis
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The goal of this prospective randomized double blinded placebo controlled study is to investigate if a single dose of ketamine in addition to standard anesthesia will reduce the risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will be utilized during the surgical procedure to evaluate its potential as a possible predictive device for delirium.
This is a single center prospective randomized double blinded placebo controlled study.
The primary aim of the study is to optimize the intraoperative treatment protocol for head and neck cancer patients to reduce the incidence of delirium and associated postoperative cognitive dysfunction. Secondary aims are to determine the dose response relationship for intraoperative ketamine and delirium reduction, determine if a single dose of ketamine will reduce post-operative pain and opioid requirements, determine if raw electroencephalogram (EEG) data can predict postoperative delirium during general anesthesia, and to evaluate length of intensive care unit (ICU) and length of hospital stay.
Participants will be randomized to one of three groups after administration of general anesthesia; one dose of .5 mg/kg intravenous (IV) Ketamine, 1.0 mg/kg of IV Ketamine, or IV placebo.
An EEG will be used during the surgical procedure to gather raw data for off line analysis among patients developing post-operative delirium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine 0.5 mg/kg | Experimental | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. |
|
| Ketamine 1.0 mg/kg | Experimental | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. |
|
| Placebo | Placebo Comparator | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as "present". Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame. | Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Behavioral Pain Scale (Non-Intubated) Score | The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain). | Post Operation (Up to 6 Hours), Post Operation Day 0 |
| Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Moll, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine 0.5 mg/kg | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| FG001 | Ketamine 1.0 mg/kg | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| FG002 | Placebo | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine 0.5 mg/kg | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score | The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as "present". Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame. | Unable to collect data in 15 participants. N=12: Provider not available. N=2 No PACU. N=1 Physician Decision (withdrawal) | Posted | Count of Participants | Participants | Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours) |
|
The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively.
If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine 0.5 mg/kg | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delirium | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amit Prabhakar | Emory University | 404-686-2747 | amit.prabhakar@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2019 | Feb 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D000077330 | Saline Solution |
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. |
|
|
| Electroencephalogram (EEG) | Device | A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
|
Scores range from 0 (no pain) to 10 (worst pain). |
| Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks) |
| Change in Mini Cog Score | The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia. | Baseline, Post Surgery (Up to 6 Weeks) |
| Change in Mini-Mental Status Examination (MMSE) Score | The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment. | Baseline, Post Surgery (Up to 6 Weeks) |
| Change in Cognitive Failure Questionnaire (CFQ) Score | The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention. | Baseline, Post Surgery (Up to 6 Weeks) |
| Post Operative Narcotics Use | The total amount of narcotics used measured in morphine milligram equivalents (MME). | Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention) |
| Associations of Intraoperative EEG Patterns With PACU Delirium | The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown. | Intraoperative EEG and delirium during PACU stay |
| Physician Decision |
|
| BG001 | Ketamine 1.0 mg/kg | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| BG002 | Placebo | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Ketamine 1.0 mg/kg | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| OG002 | Placebo | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
|
|
| Secondary | Change in Behavioral Pain Scale (Non-Intubated) Score | The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain). | Unable to collect information for this outcome. The investigators collected the pain scales from the EMR. The BPS was not routinely collected in the hospital and they only report Visual analog scale (VAS). | Posted | Post Operation (Up to 6 Hours), Post Operation Day 0 |
|
|
| Secondary | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score | Scores range from 0 (no pain) to 10 (worst pain). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks) |
|
|
|
| Secondary | Change in Mini Cog Score | The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia. | The number of participants is different from participant flow because some of the subjects did not complete the assessment. | Posted | Count of Participants | Participants | Baseline, Post Surgery (Up to 6 Weeks) |
|
|
|
| Secondary | Change in Mini-Mental Status Examination (MMSE) Score | The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment. | This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed. | Posted | Count of Participants | Participants | Baseline, Post Surgery (Up to 6 Weeks) |
|
|
|
| Secondary | Change in Cognitive Failure Questionnaire (CFQ) Score | The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention. | This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, Post Surgery (Up to 6 Weeks) |
|
|
|
| Secondary | Post Operative Narcotics Use | The total amount of narcotics used measured in morphine milligram equivalents (MME). | The population is different at 6 weeks post intervention because this outcome was not completed for some participants at that time point. | Posted | Median | Inter-Quartile Range | morphine milligram equivalents (MME) | Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention) |
|
|
|
| Secondary | Associations of Intraoperative EEG Patterns With PACU Delirium | The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown. | Only a total of 38 EEGs with sufficient quality were analyzed | Posted | Mean | Standard Deviation | Percentage of cumulative power | Intraoperative EEG and delirium during PACU stay |
|
|
|
| 0 |
| 21 |
| 4 |
| 21 |
| 3 |
| 21 |
| EG001 | Ketamine 1.0 mg/kg | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | 1 | 26 | 9 | 26 | 5 | 26 |
| EG002 | Placebo | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | 0 | 24 | 2 | 24 | 4 | 24 |
| Stroke | Nervous system disorders | Non-systematic Assessment |
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| Facial artery clot | Vascular disorders | Non-systematic Assessment |
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| Surgical wound dehiscence | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Carotid injury | Vascular disorders | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Post-operative wound abscess | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bilateral MCA; PCA transcortical acute infarcts | Nervous system disorders | Non-systematic Assessment |
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| NSTEMI | Cardiac disorders | Non-systematic Assessment |
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| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Partial flap necrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Exposed tendon of left forearm free flap | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hallucinations | Psychiatric disorders | Non-systematic Assessment |
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| Transient left sided weakness | Nervous system disorders | Non-systematic Assessment |
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| Somnolence | General disorders | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Restlessness | General disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
|
| Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 0) |
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| Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 1) |
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| Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 2) |
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| Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 3) |
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| Pain Level assessed by the Visual Analog Scale Score Post surgery (follow up visit - Up to 6 weeks) |
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| Baseline Mini Cog Score- Negative Screen |
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| Mini Cog Score Post surgery (Up to 6 weeks) - Positive Screen |
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| Mini Cog Score Post surgery (Up to 6 weeks) - Negative Screen |
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| Cognitive Impairment Baseline MMSE Score (0-24) |
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| Normal Post surgery (Up to 6 weeks) MMSE Score (25-30) |
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| Cognitive Impairment Post surgery (Up to 6 weeks) MMSE Score (0-24) |
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| CFQ Score Post surgery (Up to 6 weeks) |
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| Post Intervention (POD 0) |
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| Post Intervention (POD 1) |
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| Post Intervention (POD 2) |
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| Post Intervention (POD 3) |
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| Post Intervention (Follow up visit-up to 6 weeks) |
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| Negative Delirium for PACU |
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