<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/NCT03009409</url>
  </required_header>
  <id_info>
    <org_study_id>925-0702-DCI</org_study_id>
    <nct_id>NCT03009409</nct_id>
  </id_info>
  <brief_title>The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia</brief_title>
  <official_title>The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NeuroWave Systems Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fraser Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Office of Naval Research (ONR)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>NeuroWave Systems Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      Closed-loop control of anesthesia involves using feedback from a measure of clinical effect&#xD;
      to continuously adjust drug infusion rates. As a result, anesthetic drugs are delivered at a&#xD;
      variable rate that is frequently personalized to each individual patient. The aim is to&#xD;
      provide greater stability at an optimal depth of anesthesia, reducing the occurrence of&#xD;
      under- or overdosing, with the goal of ultimately improving patient outcomes.&#xD;
&#xD;
      The purpose of this randomized, controlled equivalence trial is to compare controller&#xD;
      performance during closed-loop controlled induction and maintenance of total intravenous&#xD;
      anesthesia, using iControl system, with the addition of a low (analgesic) dose of ketamine&#xD;
      versus saline control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the primary outcome measure, the investigators hypothesize that controller performance&#xD;
      with low-dose ketamine will be equivalent to the controller performance without low-dose&#xD;
      ketamine. The primary outcome measure, controller performance, is the percentage of time&#xD;
      during the maintenance phase when the depth-of-hypnosis (DOH) measure is within +-10 points&#xD;
      of the set point in patients receiving low dose ketamine versus those receiving saline&#xD;
      control.&#xD;
&#xD;
      This study will consider other clinical data of interest from both intra- and post-operative&#xD;
      contexts in order to establish a broader understanding of the potential implications of the&#xD;
      use of a low dose of ketamine during closed-loop controlled anesthesia. In the OR, the&#xD;
      investigators will record other indications of anesthetic quality, such as vital signs and&#xD;
      the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption&#xD;
      will be quantified, and the requirement of any other interventions will be recorded. The&#xD;
      investigators will also record post-operative patient outcomes that have previously been&#xD;
      associated with ketamine administration, such as acute post-operative pain intensity, opioid&#xD;
      requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care&#xD;
      unit (PACU).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2018</start_date>
  <completion_date type="Actual">October 17, 2018</completion_date>
  <primary_completion_date type="Actual">October 17, 2018</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Controller performance</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The primary outcome measure for this equivalence trial is 'controller performance', calculated as the percentage of time during the maintenance phase when the depth-of-hypnosis (DOH) measure is within ±10 points of the set point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vital signs</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).&#xD;
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of unwanted intra-operative events</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).&#xD;
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Propofol consumption</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).&#xD;
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remifentanil consumption</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).&#xD;
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain intensity</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).&#xD;
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing PONV</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).&#xD;
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing shivering in PACU</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).&#xD;
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Ketamine Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to the ketamine group will receive a 0.25 mg/kg loading dose of intravenous ketamine immediately before induction of anesthesia, followed by a continuous 5 mcg/kg/min infusion throughout maintenance of anesthesia, for approximately 45 minutes, up to a maximum cumulative dose of 100 mg. This dose is in accordance with the guidelines from the recently published Clinical Practice Guidelines for the management of post-operative pain. The attending anesthesiologist will confirm whether the use of ketamine is appropriate for each patient prior to enrolling the patient in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in the control group will receive an equivalent volume bolus and infusion of normal saline to mimic the ketamine infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine Injectable Solution</intervention_name>
    <description>Once IV access has been obtained and a facemask has been applied for pre-oxygenation, the loading dose (0.25 mg/kg) of the study drug will be given over 60 seconds and the fixed infusion (5 mcg/kg/min to a maximum of 60 mg/hour) will be initiated by the anesthetist through the pump interface.&#xD;
The study drug will be infused at a constant rate of 5 mcg/kg/min throughout the maintenance phase, until the end of the procedure (last suture), up to a maximum cumulative dose of 100 mg. If at any point the anesthesiologist feels that it is clinically necessary to reduce the amount of study drug infusion rate, they may opt to reduce the infusion rate by 50% (to 2.5 mcg/kg/min), or stop the infusion entirely.</description>
    <arm_group_label>Ketamine Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants in the control group will receive an equivalent volume bolus and infusion of normal saline to mimic the ketamine infusion in the ketamine group.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19-54&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  BMI 15-45&#xD;
&#xD;
          -  Elective ACL repair surgery requiring general anesthesia&#xD;
&#xD;
          -  Ability to read and understand the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to ketamine use Those in whom a significant elevation of blood&#xD;
             pressure would constitute a serious hazard (e.g. severe cardiovascular disease,&#xD;
             pacemaker, pheochromocytoma, malignant hypertension, intraocular pressure pathology,&#xD;
             acute globe injury, hyperthyroidism)&#xD;
&#xD;
          -  Contraindications to propofol Anaphylactic reaction to eggs, egg products, soybeans or&#xD;
             soy products&#xD;
&#xD;
          -  Contraindications to remifentanil Hypersensitivity to fentanyl analogues&#xD;
&#xD;
          -  Known or suspected neurological disease Tumor, stroke, neurodegenerative disease,&#xD;
             major head injury, seizure disorder Abnormality in any previous EEG examination&#xD;
             Cognitive deficits (e.g. dementia, developmental delay)&#xD;
&#xD;
          -  Acquired scalp or skull abnormalities&#xD;
&#xD;
          -  Psychiatric illness Severe depression, PTSD, psychosis Any psychotropic medication&#xD;
             taken in the past 7 days&#xD;
&#xD;
          -  History of drug misuse/abuse within past 30 days Ketamine, cocaine, heroin,&#xD;
             amphetamines, phencyclindine, lysergic acid (LSD), mescaline, psilocybin Chronic&#xD;
             alcoholism&#xD;
&#xD;
          -  Requirement for pre-operative sedative medication (e.g. midazolam) for anxiolysis&#xD;
&#xD;
          -  Anticipated intra-operative or pre-operative use of nitrous oxide, catecholamines&#xD;
             (dopamine, epinephrine, norepinephrine) or thyroid hormones&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Currently enrolled in any other research study involving drugs or devices&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Merchant, MD FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fraser Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fraser Health: Eagle Ridge Hospital</name>
      <address>
        <city>Port Moody</city>
        <state>British Columbia</state>
        <zip>V3H 3W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03009409
org study id: 925-0702-DCI
nct id: NCT03009409
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Closed-loop control of anesthesia involves using feedback from a measure of clinical effect
      to continuously adjust drug infusion rates. As a result, anesthetic drugs are delivered at a
      variable rate that is frequently personalized to each individual patient. The aim is to
      provide greater stability at an optimal depth of anesthesia, reducing the occurrence of
      under- or overdosing, with the goal of ultimately improving patient outcomes.

      The purpose of this randomized, controlled equivalence trial is to compare controller
      performance during closed-loop controlled induction and maintenance of total intravenous
      anesthesia, using iControl system, with the addition of a low (analgesic) dose of ketamine
      versus saline control.
For the primary outcome measure, the investigators hypothesize that controller performance
      with low-dose ketamine will be equivalent to the controller performance without low-dose
      ketamine. The primary outcome measure, controller performance, is the percentage of time
      during the maintenance phase when the depth-of-hypnosis (DOH) measure is within +-10 points
      of the set point in patients receiving low dose ketamine versus those receiving saline
      control.

      This study will consider other clinical data of interest from both intra- and post-operative
      contexts in order to establish a broader understanding of the potential implications of the
      use of a low dose of ketamine during closed-loop controlled anesthesia. In the OR, the
      investigators will record other indications of anesthetic quality, such as vital signs and
      the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption
      will be quantified, and the requirement of any other interventions will be recorded. The
      investigators will also record post-operative patient outcomes that have previously been
      associated with ketamine administration, such as acute post-operative pain intensity, opioid
      requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care
      unit (PACU).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Controller performance
time frame: Through study completion, an average of 1 year
description: The primary outcome measure for this equivalence trial is 'controller performance', calculated as the percentage of time during the maintenance phase when the depth-of-hypnosis (DOH) measure is within ±10 points of the set point.
measure: Vital signs
time frame: Through study completion, an average of 1 year
description: In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.
measure: Number of unwanted intra-operative events
time frame: Through study completion, an average of 1 year
description: In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.
measure: Propofol consumption
time frame: Through study completion, an average of 1 year
description: In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.
measure: Remifentanil consumption
time frame: Through study completion, an average of 1 year
description: In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.
measure: Post-operative pain intensity
time frame: Through study completion, an average of 1 year
description: In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.
measure: Number of participants experiencing PONV
time frame: Through study completion, an average of 1 year
description: In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.
measure: Number of participants experiencing shivering in PACU
time frame: Through study completion, an average of 1 year
description: In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU).
Analysis of group differences in secondary intra-operative and post-operative measures will be mainly exploratory, as this study was not designed to detect a definitive difference between these variables. Rather, these data may contribute to a developing body of evidence elucidating the potential benefits of low dose ketamine. Any outliers will be described and discussed on a case-by-base / incidence basis.
arm group label: Ketamine Group
arm group type: Active Comparator
description: Participants randomized to the ketamine group will receive a 0.25 mg/kg loading dose of intravenous ketamine immediately before induction of anesthesia, followed by a continuous 5 mcg/kg/min infusion throughout maintenance of anesthesia, for approximately 45 minutes, up to a maximum cumulative dose of 100 mg. This dose is in accordance with the guidelines from the recently published Clinical Practice Guidelines for the management of post-operative pain. The attending anesthesiologist will confirm whether the use of ketamine is appropriate for each patient prior to enrolling the patient in the study.
arm group label: Control Group
arm group type: Placebo Comparator
description: Participants in the control group will receive an equivalent volume bolus and infusion of normal saline to mimic the ketamine infusion.
intervention type: Drug
intervention name: Ketamine Injectable Solution
description: Once IV access has been obtained and a facemask has been applied for pre-oxygenation, the loading dose (0.25 mg/kg) of the study drug will be given over 60 seconds and the fixed infusion (5 mcg/kg/min to a maximum of 60 mg/hour) will be initiated by the anesthetist through the pump interface.
The study drug will be infused at a constant rate of 5 mcg/kg/min throughout the maintenance phase, until the end of the procedure (last suture), up to a maximum cumulative dose of 100 mg. If at any point the anesthesiologist feels that it is clinically necessary to reduce the amount of study drug infusion rate, they may opt to reduce the infusion rate by 50% (to 2.5 mcg/kg/min), or stop the infusion entirely.
arm group label: Ketamine Group
intervention type: Other
intervention name: Placebo
description: Participants in the control group will receive an equivalent volume bolus and infusion of normal saline to mimic the ketamine infusion in the ketamine group.
arm group label: Control Group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 54 Years
healthy volunteers: No
last name: Richard Merchant, MD FRCPC
role: Principal Investigator
affiliation: Fraser Health
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Ketamine