xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05993754</url>
    </required_header>
    <id_info>
      <org_study_id>220727001</org_study_id>
      <nct_id>NCT05993754</nct_id>
    </id_info>
    <brief_title>Non-pharmacological Prevention of POD in Frailty Elderly Undergoing Elective Surgery Applied by Nursing Teams</brief_title>
    <acronym>NPPOD</acronym>
    <official_title>Impact of Non-pharmacological Measures Applied by the Nursing Team in Reducing the Incidence of Postoperative Delirium During the Postoperative and 24hr After Surgery in Frail Elderly Undergoing Elective Non-cardiac Surgeries.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pontificia Universidad Catolica de Chile</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pontificia Universidad Catolica de Chile</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The increase in the population over 60 years of age who could receive surgery due to changes&#xD;
        in life expectancy and advances in surgical and anesthetic techniques.&#xD;
  &#xD;
        Likewise, elderly people (EP) may have a higher risk of postoperative morbidity and mortality&#xD;
        compared to young people, with frailty being one of the risk factors that increases adverse&#xD;
        outcomes in this period and increases the probability of developing syndromes such as&#xD;
        postoperative delirium (POD).&#xD;
  &#xD;
        Assessment of frailty in EP prior to surgery is not routine, so it is unknown how many frail&#xD;
        and/or pre-frail EP undergo surgery in health care systems. There is an association between&#xD;
        being frail and developing greater delirium and/or postoperative cognitive deficit, which in&#xD;
        summary translates into an increase in perioperative morbidity and mortality.&#xD;
  &#xD;
        For the prevention of POD, there are pharmacological and non-pharmacological measures that&#xD;
        seek to promote orientation with respect to their environment and make it as familiar as&#xD;
        possible, stimulate early aspects of memory and thinking skills, as well as promote sleep&#xD;
        using environmental hygiene measures.&#xD;
  &#xD;
        In Chile, protocols of non-pharmacological measures have been proposed by occupational&#xD;
        therapy teams, which have had positive results in reducing POD in frail elderly patients.&#xD;
        These measures are temporal-spatial reorientation, physical mobilization, correction of&#xD;
        sensory deficits, environmental management, sleep protocol, and reduction of anticholinergic&#xD;
        drugs with statistically significant results in the reduction of POD.&#xD;
  &#xD;
        In accordance with the above, the objective of this study is to evaluate the impact of&#xD;
        non-pharmacological measures applied by the nursing team in reducing the incidence of POD&#xD;
        during the post-surgical period in fragile and pre-fragile EP undergoing elective non-cardiac&#xD;
        surgeries.&#xD;
  &#xD;
        It is expected that in the end, frail and pre-frail EP who receive non-pharmacological&#xD;
        interventions by the nursing team will present a lower incidence of POD at 24 hours compared&#xD;
        to those who receive traditional care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will correspond to frail and pre-frail people over 65 years of age who undergo&#xD;
        elective non-cardiac surgery that requires general anesthesia and who attend the UC-Christus&#xD;
        Clinical Hospital.&#xD;
  &#xD;
        Frailty instruments (FRAIL scale) and Clinical Frailty Scale (CFS) will be applied, together&#xD;
        with a preoperative cognition test (MiniCog; in case of presenting an altered result, the&#xD;
        Montreal Cognitive Assessment, MoCA instrument will be applied), the delirium screening test&#xD;
        (Delirium Triage Screen, DTS; in case of presenting an altered result, the Confusion&#xD;
        Assessment Method instrument will be applied. d, CAM). Then, the participants will be&#xD;
        randomized into two groups:&#xD;
  &#xD;
          1. A first group to which a protocol of non-pharmacological interventions implemented by&#xD;
             the nursing team will be applied to prevent post-surgical delirium&#xD;
  &#xD;
          2. A second control group that will only receive traditional care. The users of the first&#xD;
             group who use glasses, hearing aids and/or removable dental prostheses will move from&#xD;
             the pre-operative unit room to the surgical ward with these elements, which will be&#xD;
             delivered to their caregiver or companion after the safety break and before starting&#xD;
             anesthesia inside the ward room where they will be operated on.&#xD;
  &#xD;
        Both groups will undergo standard monitoring (ECG, NIBP, SatO2) and anesthesia will be guided&#xD;
        using frontal EEG (SedLine or bilateral BIS). During the intraoperative period, an effort&#xD;
        will be made to maintain a Mean Blood Pressure ± 20% of baseline and to keep the patient&#xD;
        normothermic.&#xD;
  &#xD;
        In the postoperative stage, therapeutic activities of cognitive stimulation and socialization&#xD;
        will be carried out where temporal-spatial information will be delivered, the visit of the&#xD;
        companion will be coordinated, a protocolized mobilization routine will be carried out&#xD;
        considering pain, state of consciousness, thromboembolic risk and risk of falls. In the event&#xD;
        that she does not want or cannot carry out the protocolized mobilization routine,&#xD;
        non-pharmacological sleep will be privileged.&#xD;
  &#xD;
        One hour after the patient's admission to the recovery unit, a delirium evaluation will be&#xD;
        performed using CAM by personnel other than the one who performed the non-pharmacological&#xD;
        measures. Two hours later, the non-pharmacological measures will be reinforced and later a&#xD;
        new evaluation of delirium will be applied using CAM.&#xD;
  &#xD;
        An evaluation of delirium will be carried out during the morning by means of CAM 24 hours&#xD;
        after the admission of the patient to the recovery unit by a person other than the nursing&#xD;
        team, who has not applied the protocol of non-pharmacological measures.&#xD;
  &#xD;
        If the elderly person is still hospitalized, a final delirium evaluation will be carried out&#xD;
        by means of CAM during the afternoon (24 hours after admission to the recovery unit).&#xD;
  &#xD;
        In the event that the person presents CAM (+), the application of non-pharmacological&#xD;
        measures will be evaluated with the treating team and the respective interconsultation will&#xD;
        be processed with the geriatric team of the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Control group and intervention group</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>After signed informed consent at the preoperative unit and during the post anesthesia unit care</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative delirum (POD)</measure>
      <time_frame>: 10 minutes, 60 minutes, 120 minutes, 720 minutes and 1440 minutes after anesthesia</time_frame>
      <description>Neurocognitive syndrome can occur from anywhere after anesthesia measure using the Confusion assessment method (CAM). For a diagnosis of delirium by CAM, the patient must display presence of acute onset and fluctuating discourse and Inattention, and either disorganized thinking or Altered level of consciousness (positive CAM), otherwise, the result is negative (negative CAM).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Frailty _FRAIL</measure>
      <time_frame>Pre Anesthesia period at same day of the surgery</time_frame>
      <description>Frailty elderly measure by FRAIL Scale. It assesses 5 components: fatigue, resistance, ambulation, illnesses, and loss of weight. The score goes from 0 to 5 and represents the state of health and each component is worth 1 point, where it is recorded as robust (0), pre-frail (1-2) and fragile (3-5).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frailty_CFS</measure>
      <time_frame>Pre Anesthesia period at same day of the surgery</time_frame>
      <description>Frailty elderly measure by Clinical Frailty Scale (CFS). Present a score from 1 (very fit) to 9 (terminally ill) is given based on the descriptions and pictographs of activity and functional status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Screening of Cognitive impairment_MiniCog</measure>
      <time_frame>Pre Anesthesia period at same day of the surgery</time_frame>
      <description>Using Mini-Cog Score: 0 to 2 indicates possible cognitive disorder; 3 to 5 indicates no cognitive disorder.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Possible Cognitive impairment_MoCA</measure>
      <time_frame>Pre Anesthesia period at same day of the surgery</time_frame>
      <description>Measure by Montreal Cognitive Assessment (MoCA) test The cut-off point for MCI-a is &lt;21 and for mild dementia &lt;20. If the person has less than 12 years of schooling, 1 point is added.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Risk of anesthesia</measure>
      <time_frame>Pre Anesthesia period at same day of the surgery</time_frame>
      <description>Using the American Society of Anesthesiologists (ASA) classification. Categorize the patient's risk of undergoing any procedure that requires anesthesia, allowing to assess their physiological state and systemic diseases. The ASA score is based on five classes (I to V).&#xD;
  I. Patient is a completely healthy fit patient. II. Patient has mild systemic disease. III. Patient has severe systemic disease that is not incapacitating. IV. Patient has incapacitating disease that is a constant threat to life. V. A moribund patient who is not expected to live 24 hour with or without surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Type of surgery</measure>
      <time_frame>Pre Anesthesia period at same day of the surgery</time_frame>
      <description>Classification of surgery by specialty</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Educational level of chile</measure>
      <time_frame>Pre Anesthesia period at same day of the surgery</time_frame>
      <description>Using the number of years of formal learning</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Type of Anesthesia</measure>
      <time_frame>Up to 30 minutes after the end of the surgery</time_frame>
      <description>Classification type of anesthesia (Total Intravenous anesthesia, Total inhalation anesthesia and/or other)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Electroencephalogram monitoring during the anesthesia</measure>
      <time_frame>Up to 30 minutes after the end of the surgery</time_frame>
      <description>Measure by electroencephalogram (EEG) monitor (SedLine or BIS). From the start of anesthesia to the end of it.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Type of drugs during anesthesia</measure>
      <time_frame>Up to 30 minutes after the end of the surgery</time_frame>
      <description>According of classification type of anesthesia, amount of total drugs (mg, mcg, %etgas and/or other) General anesthesia (gas-based anesthesia or total intravenous anesthesia)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Pain</measure>
      <time_frame>10 minutes, 60 minutes, 120 minutes, 720 minutes and 1440 minutes after anesthesia</time_frame>
      <description>Measure by Numerical Rating Scale (NRS) pain The patient indicates the degree of pain on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positive POD Positive CAM: presence of post-operative delirium (POD) Negative CAM:. absence of postoperative delirium (POD)</measure>
      <time_frame>720 minutes and 1440 minutes after anesthesia</time_frame>
      <description>Measure by type of pharmacological measure by type of pharmacological management</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Frail Elderly Syndrome</condition>
    <condition>Primary Prevention</condition>
    <condition>Postoperative Delirium</condition>
    <condition>Frailty</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Frail and pre-frail elderly people over 65 years of age who underwent elective non-cardiac surgeries who receive non-pharmacological interventions by the nursing team</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Frail and pre-frail elderly people over 65 years of age undergoing elective non-cardiac surgeries who will receive traditional care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Non-pharmacological intervention</intervention_name>
      <description>The intervention consists of six main elements:&#xD;
  Correction of sensory deficits: Before surgery, the use of glasses, hearing aids and/or removable dental prostheses will be allowed, which will be removed before starting anesthesia in the emergency room. After surgery, they will be delivered back to the user.&#xD;
  Reorientation: In the postoperative period, the person will be informed where they are and the visit of the companion will be coordinated.&#xD;
  Early mobilization: A protocolized mobilization routine will be applied according to pain, state of consciousness, risk of thromboembolic disease and risk of falls.&#xD;
  Environmental management: You will be shown the time on a clock, it will reinforce the idea of the place where you are and that you can count on the team in case you need assistance.&#xD;
  Sleep protocol: The elderly person who does not want or cannot perform the mobilization routine, non-pharmacological sleep will be privileged.&#xD;
  Reduction of anticholinergic drugs</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients older than 65 years&#xD;
  &#xD;
            -  Elective non-cardiac surgery&#xD;
  &#xD;
            -  General anesthesia with Bilateral BIS electroencephalographic monitoring or SedLine&#xD;
  &#xD;
            -  ASA I, II or III.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Neurosurgical patients&#xD;
  &#xD;
            -  History of alcohol and/or drug abuse&#xD;
  &#xD;
            -  History of recreational psychoactive drug use&#xD;
  &#xD;
            -  Allergy to anesthetic drugs.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Victor Contreras, MSN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Pontificia Universidad Catolica de Chile</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Victor Contreras, MSN</last_name>
      <phone>+56955049217</phone>
      <email>vecontre@uc.cl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Karen Azagra, BcS</last_name>
      <phone>+56955049217</phone>
      <email>karen.azagra@uc.cl</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Delirium</keyword>
    <keyword>Non-pharmacological</keyword>
    <keyword>Elderly</keyword>
    <keyword>Frailty</keyword>
    <keyword>Nursing</keyword>
    <keyword>Postoperative</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Delirium</mesh_term>
      <mesh_term>Emergence Delirium</mesh_term>
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05993754
  org study id: 220727001
  nct id: NCT05993754
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The increase in the population over 60 years of age who could receive surgery due to changes
        in life expectancy and advances in surgical and anesthetic techniques.
  
        Likewise, elderly people (EP) may have a higher risk of postoperative morbidity and mortality
        compared to young people, with frailty being one of the risk factors that increases adverse
        outcomes in this period and increases the probability of developing syndromes such as
        postoperative delirium (POD).
  
        Assessment of frailty in EP prior to surgery is not routine, so it is unknown how many frail
        and/or pre-frail EP undergo surgery in health care systems. There is an association between
        being frail and developing greater delirium and/or postoperative cognitive deficit, which in
        summary translates into an increase in perioperative morbidity and mortality.
  
        For the prevention of POD, there are pharmacological and non-pharmacological measures that
        seek to promote orientation with respect to their environment and make it as familiar as
        possible, stimulate early aspects of memory and thinking skills, as well as promote sleep
        using environmental hygiene measures.
  
        In Chile, protocols of non-pharmacological measures have been proposed by occupational
        therapy teams, which have had positive results in reducing POD in frail elderly patients.
        These measures are temporal-spatial reorientation, physical mobilization, correction of
        sensory deficits, environmental management, sleep protocol, and reduction of anticholinergic
        drugs with statistically significant results in the reduction of POD.
  
        In accordance with the above, the objective of this study is to evaluate the impact of
        non-pharmacological measures applied by the nursing team in reducing the incidence of POD
        during the post-surgical period in fragile and pre-fragile EP undergoing elective non-cardiac
        surgeries.
  
        It is expected that in the end, frail and pre-frail EP who receive non-pharmacological
        interventions by the nursing team will present a lower incidence of POD at 24 hours compared
        to those who receive traditional care.
  Participants will correspond to frail and pre-frail people over 65 years of age who undergo
        elective non-cardiac surgery that requires general anesthesia and who attend the UC-Christus
        Clinical Hospital.
  
        Frailty instruments (FRAIL scale) and Clinical Frailty Scale (CFS) will be applied, together
        with a preoperative cognition test (MiniCog; in case of presenting an altered result, the
        Montreal Cognitive Assessment, MoCA instrument will be applied), the delirium screening test
        (Delirium Triage Screen, DTS; in case of presenting an altered result, the Confusion
        Assessment Method instrument will be applied. d, CAM). Then, the participants will be
        randomized into two groups:
  
          1. A first group to which a protocol of non-pharmacological interventions implemented by
             the nursing team will be applied to prevent post-surgical delirium
  
          2. A second control group that will only receive traditional care. The users of the first
             group who use glasses, hearing aids and/or removable dental prostheses will move from
             the pre-operative unit room to the surgical ward with these elements, which will be
             delivered to their caregiver or companion after the safety break and before starting
             anesthesia inside the ward room where they will be operated on.
  
        Both groups will undergo standard monitoring (ECG, NIBP, SatO2) and anesthesia will be guided
        using frontal EEG (SedLine or bilateral BIS). During the intraoperative period, an effort
        will be made to maintain a Mean Blood Pressure ± 20% of baseline and to keep the patient
        normothermic.
  
        In the postoperative stage, therapeutic activities of cognitive stimulation and socialization
        will be carried out where temporal-spatial information will be delivered, the visit of the
        companion will be coordinated, a protocolized mobilization routine will be carried out
        considering pain, state of consciousness, thromboembolic risk and risk of falls. In the event
        that she does not want or cannot carry out the protocolized mobilization routine,
        non-pharmacological sleep will be privileged.
  
        One hour after the patient's admission to the recovery unit, a delirium evaluation will be
        performed using CAM by personnel other than the one who performed the non-pharmacological
        measures. Two hours later, the non-pharmacological measures will be reinforced and later a
        new evaluation of delirium will be applied using CAM.
  
        An evaluation of delirium will be carried out during the morning by means of CAM 24 hours
        after the admission of the patient to the recovery unit by a person other than the nursing
        team, who has not applied the protocol of non-pharmacological measures.
  
        If the elderly person is still hospitalized, a final delirium evaluation will be carried out
        by means of CAM during the afternoon (24 hours after admission to the recovery unit).
  
        In the event that the person presents CAM (+), the application of non-pharmacological
        measures will be evaluated with the treating team and the respective interconsultation will
        be processed with the geriatric team of the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Control group and intervention group
  primary purpose: Prevention
  masking: Double (Participant, Care Provider)
  masking description: After signed informed consent at the preoperative unit and during the post anesthesia unit care
  measure: Postoperative delirum (POD)
  time frame: : 10 minutes, 60 minutes, 120 minutes, 720 minutes and 1440 minutes after anesthesia
  description: Neurocognitive syndrome can occur from anywhere after anesthesia measure using the Confusion assessment method (CAM). For a diagnosis of delirium by CAM, the patient must display presence of acute onset and fluctuating discourse and Inattention, and either disorganized thinking or Altered level of consciousness (positive CAM), otherwise, the result is negative (negative CAM).
  measure: Frailty _FRAIL
  time frame: Pre Anesthesia period at same day of the surgery
  description: Frailty elderly measure by FRAIL Scale. It assesses 5 components: fatigue, resistance, ambulation, illnesses, and loss of weight. The score goes from 0 to 5 and represents the state of health and each component is worth 1 point, where it is recorded as robust (0), pre-frail (1-2) and fragile (3-5).
  measure: Frailty_CFS
  time frame: Pre Anesthesia period at same day of the surgery
  description: Frailty elderly measure by Clinical Frailty Scale (CFS). Present a score from 1 (very fit) to 9 (terminally ill) is given based on the descriptions and pictographs of activity and functional status.
  measure: Screening of Cognitive impairment_MiniCog
  time frame: Pre Anesthesia period at same day of the surgery
  description: Using Mini-Cog Score: 0 to 2 indicates possible cognitive disorder; 3 to 5 indicates no cognitive disorder.
  measure: Possible Cognitive impairment_MoCA
  time frame: Pre Anesthesia period at same day of the surgery
  description: Measure by Montreal Cognitive Assessment (MoCA) test The cut-off point for MCI-a is <21 and for mild dementia <20. If the person has less than 12 years of schooling, 1 point is added.
  measure: Risk of anesthesia
  time frame: Pre Anesthesia period at same day of the surgery
  description: Using the American Society of Anesthesiologists (ASA) classification. Categorize the patient's risk of undergoing any procedure that requires anesthesia, allowing to assess their physiological state and systemic diseases. The ASA score is based on five classes (I to V).
  I. Patient is a completely healthy fit patient. II. Patient has mild systemic disease. III. Patient has severe systemic disease that is not incapacitating. IV. Patient has incapacitating disease that is a constant threat to life. V. A moribund patient who is not expected to live 24 hour with or without surgery.
  measure: Type of surgery
  time frame: Pre Anesthesia period at same day of the surgery
  description: Classification of surgery by specialty
  measure: Educational level of chile
  time frame: Pre Anesthesia period at same day of the surgery
  description: Using the number of years of formal learning
  measure: Type of Anesthesia
  time frame: Up to 30 minutes after the end of the surgery
  description: Classification type of anesthesia (Total Intravenous anesthesia, Total inhalation anesthesia and/or other)
  measure: Electroencephalogram monitoring during the anesthesia
  time frame: Up to 30 minutes after the end of the surgery
  description: Measure by electroencephalogram (EEG) monitor (SedLine or BIS). From the start of anesthesia to the end of it.
  measure: Type of drugs during anesthesia
  time frame: Up to 30 minutes after the end of the surgery
  description: According of classification type of anesthesia, amount of total drugs (mg, mcg, %etgas and/or other) General anesthesia (gas-based anesthesia or total intravenous anesthesia)
  measure: Postoperative Pain
  time frame: 10 minutes, 60 minutes, 120 minutes, 720 minutes and 1440 minutes after anesthesia
  description: Measure by Numerical Rating Scale (NRS) pain The patient indicates the degree of pain on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.
  measure: Positive POD Positive CAM: presence of post-operative delirium (POD) Negative CAM:. absence of postoperative delirium (POD)
  time frame: 720 minutes and 1440 minutes after anesthesia
  description: Measure by type of pharmacological measure by type of pharmacological management
  arm group label: Intervention group
  arm group type: Experimental
  description: Frail and pre-frail elderly people over 65 years of age who underwent elective non-cardiac surgeries who receive non-pharmacological interventions by the nursing team
  arm group label: Control group
  arm group type: No Intervention
  description: Frail and pre-frail elderly people over 65 years of age undergoing elective non-cardiac surgeries who will receive traditional care.
  intervention type: Other
  intervention name: Non-pharmacological intervention
  description: The intervention consists of six main elements:
  Correction of sensory deficits: Before surgery, the use of glasses, hearing aids and/or removable dental prostheses will be allowed, which will be removed before starting anesthesia in the emergency room. After surgery, they will be delivered back to the user.
  Reorientation: In the postoperative period, the person will be informed where they are and the visit of the companion will be coordinated.
  Early mobilization: A protocolized mobilization routine will be applied according to pain, state of consciousness, risk of thromboembolic disease and risk of falls.
  Environmental management: You will be shown the time on a clock, it will reinforce the idea of the place where you are and that you can count on the team in case you need assistance.
  Sleep protocol: The elderly person who does not want or cannot perform the mobilization routine, non-pharmacological sleep will be privileged.
  Reduction of anticholinergic drugs
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Victor Contreras, MSN
  role: Principal Investigator
  affiliation: Pontificia Universidad Catolica de Chile
  last name: Victor Contreras, MSN
  phone: +56955049217
  email: vecontre@uc.cl
  last name: Karen Azagra, BcS
  phone: +56955049217
  email: karen.azagra@uc.cl
  responsible party type: Sponsor
  mesh term: Delirium
  mesh term: Emergence Delirium
  mesh term: Frailty