<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/NCT03781635</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1482</org_study_id>
    <nct_id>NCT03781635</nct_id>
  </id_info>
  <brief_title>Comparison of BIS Index Variations: Bolus Versus Infusion Ketamine, and Impact on the Anesthesia Gas Consumption</brief_title>
  <acronym>KETABIS</acronym>
  <official_title>Comparison of BIS Index Variations When i.v. Low-dose Ketamine is Administered Intraoperatively as Bolus Versus Continuous Infusion and Impact on the Anesthesia Gas Consumption.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ciusss de L'Est de l'Île de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ciusss de L'Est de l'Île de Montréal</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to show that i.v. ketamine boluses might lead to significant&#xD;
      and clinically relevant BIS index increase that might lead to an increase in anesthesia&#xD;
      dosing (halogenous gas) when compared to an i.v. continuous infusion of ketamine without any&#xD;
      bolus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis: The investigators hypothesize that BIS will not vary when ketamine is given as an&#xD;
      i.v. infusion whereas BIS index will significantly vary when ketamine is given as&#xD;
      intraoperative repeated bolus on an hourly basis. As a consequence, the bolus group might&#xD;
      have a higher consumption of halogenous gases to keep BIS within normal values during&#xD;
      anesthesia.&#xD;
&#xD;
      Background: ketamine is a pure NMDA-receptor antagonist widely used in anesthesia for its&#xD;
      anesthetic and analgesic properties. However, boluses of intravenous ketamine have been&#xD;
      reported to increase BIS values. The present study is the first to compare ketamine effect on&#xD;
      BIS values when given as an infusion versus repeated boluses.&#xD;
&#xD;
      Objectives: primary objective: to measure the changes in BIS index values (delta BIS) after&#xD;
      each bolus of i.v. ketamine 0.25mg.kg-1 given during anesthesia for surgeries lasting more&#xD;
      than 3hs, and to demonstrate a significant increase of this BIS index whereas no significant&#xD;
      increase is expected when i.v. ketamine is given as a continuous infusion intraoperatively.&#xD;
      Secondary objectives: to measure the changes of BIS index values area under the curve when an&#xD;
      infusion of i.v. ketamine 0.25mg.kg-1.h-1 is administered to the patient instead of boluses;&#xD;
      to evaluate the time in minutes for the BIS index values to return within +/-10% of the&#xD;
      pre-bolus values of this BIS index; to evaluate the time in seconds at which the peak of BIS&#xD;
      will occur after ketamine bolus; to evaluate the consumption of halogenous gases during the&#xD;
      entire surgery and for each hour of anesthesia (T0 = incision = time for first bolus of&#xD;
      ketamine or start of ketamine infusion); to evaluate hemodynamic data (all the data from the&#xD;
      ventilator and the monitor are recorded and exported per second) in both groups and see if&#xD;
      the infusion group shows less hypotension events needing treatment with i.v. phenylephrine to&#xD;
      stay within +/-20% of the mean blood pressure baseline; to evaluate the time for awakening,&#xD;
      time for extubation, time spent in post-anesthesia care unit (PACU), delirium and cognitive&#xD;
      functions in PACU (CAMshort assessment and MOCA).&#xD;
&#xD;
      Methods: REB from CR-HMR will be obtained. 50 patients undergoing elective general,&#xD;
      urological, gynecological surgeries will be explained the study at the pre-anesthesia&#xD;
      consultation and then fully consented the day of the surgery. Anesthesia protocol will be&#xD;
      fully standardized in both the groups. BIS monitoring will be installed before induction of&#xD;
      general anesthesia as well as the standard anesthesia monitoring. Randomization into group&#xD;
      infusion versus boluses of ketamine will be done prior to the entrance in the OR, the day of&#xD;
      the surgery. Ketamine will be given as follows: in the i.v. ketamine infusion group, an&#xD;
      infusion of 0.25 mg.kg-1.h-1 is started with an infusion pump and is kept at the same rate&#xD;
      until the surgical team starts closing the deep layers of the abdominal incision. Consumption&#xD;
      of the infusion pump is noted at T0 (incision) and at each hour during the surgery and when&#xD;
      the infusion is discontinued. In the i.v. ketamine bolus group, 0.25mg.kg-1 of ketamine will&#xD;
      be first administered at the time of incision (T0) then every single hour for the rest of the&#xD;
      surgery. Study starts at anesthesia induction and incision (T0) for ketamine administration&#xD;
      and ends when the patient leaves the PACU. Objectives of the study are cited above.&#xD;
&#xD;
      Data analysis: statistical analyses will be done using SAS version 9.4 or higher and will be&#xD;
      performed at a two-sided 0.05 significance level.&#xD;
&#xD;
      Significance/Importance: This is the first study that will compare the impact of the&#xD;
      classical intraoperative ketamine administered as repeated i.v. boluses versus as a&#xD;
      continuous i.v. infusion during major surgeries lasting more than 3 hours.&#xD;
&#xD;
      Study Design: open label study, with two controlled randomized parallel groups&#xD;
&#xD;
      Subject Population: ASA 1 to 3 adult patients scheduled to undergo elective general, urologic&#xD;
      or gynecological surgeries.&#xD;
&#xD;
      Sample Size: 50 patients will be evaluated in this study.&#xD;
&#xD;
      Study Duration: 10 months.&#xD;
&#xD;
      Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal, Montreal,&#xD;
      Quebec, Canada.&#xD;
&#xD;
      Adverse Events: None expected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 29, 2019</primary_completion_date>
  <phase>Phase 4</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>Two groups of patients. Randomization into group infusion versus boluses of ketamine according to a randomization list for a total number of patients of 50.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomization into group infusion versus boluses of ketamine will be done prior to the entrance in the OR, the day of the surgery</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the increase of the BIS index (absolute value between 0 to 100) after each intravenous ketamine bolus</measure>
    <time_frame>Intraoperative, during anesthesia</time_frame>
    <description>To demonstrate and quantify à significant increase of the BIS index after each bolus of 0.25 mg.kg-1 ketamine given during surgeries lasting 3 hours and more, compared to an equivalent dose of ketamine given as a continuous infusion. Boluses of ketamine will start at T0 = incision and then will be repeated every hour for the duration of the surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of BIS values from T0=incision until end of the anesthesia, value without unit (area under curve)</measure>
    <time_frame>Intraoperative, during anesthesia</time_frame>
    <description>To compare the BIS index values area under the curve from T0=incision until end of anesthesia when i.v. ketamine 0.25mg.kg-1.h-1 is administered as an infusion or as hourly boluses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for BIS to return within 10% of the baseline values (in minutes)</measure>
    <time_frame>Intraoperative, during anesthesia</time_frame>
    <description>To evaluate the time in minutes for the BIS index values to return within +/-10% of the values the BIS index had before the bolus of ketamine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach the peak of BIS index after intravenous bolus of ketamine</measure>
    <time_frame>Intraoperative, during anesthesia</time_frame>
    <description>To evaluate the time in seconds at which the peak of BIS will occur after intravenous ketamine bolus 0.25mg/kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the consumption of halogenous gases (desflurane) during each hour of anesthesia in ml/kg/h of gas</measure>
    <time_frame>Intraoperative, during anesthesia</time_frame>
    <description>To evaluate the consumption of halogenous gases (desflurane) during each hour of anesthesia in ml/kg/h.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the consumption of phenylephrine in mcg/kg/h for each hour of anesthesia.</measure>
    <time_frame>Intraoperative, during anesthesia</time_frame>
    <description>To evaluate the need of intravenous phenylephrine given during each hour of anesthesia in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the blood pressure during each hour of anesthesia.</measure>
    <time_frame>Intraoperative, during anesthesia</time_frame>
    <description>To evaluate blood pressure recorded electronically during the whole anesthesia and to evaluate the impact of intravenous bolus of ketamine 0.25mg/kg on blood pressure during the whole hour following each bolus administration (given hourly).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the time in minutes necessary to extubatne the patient at the end of the surgery</measure>
    <time_frame>End of surgery</time_frame>
    <description>To evaluate the time for extubation in minutes at the end of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the time in minutes to reach an Alerte score of &gt;9 in post-anesthesia care unit</measure>
    <time_frame>In post anesthesia care unit, 2 hours after surgery is done</time_frame>
    <description>To evaluate the time in minutes to reach an alerte score (this score has no unit) of more than 9.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the MOCA score (score from 0 to 30) in PACU at 15 minutes after arrival in PACU (post-anesthesia care unit)</measure>
    <time_frame>15 minutes after arrival in PACU</time_frame>
    <description>To evaluate the MOCA score (0 to 30) in PACU at 15minutes after arrival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the MOCA score (score from 0 to 30) in PACU at 45 minutes after arrival in PACU (post-anesthesia care unit)</measure>
    <time_frame>45 minutes after arrival in PACU</time_frame>
    <description>To evaluate the MOCA score (0 to 30) in PACU at 45minutes after arrival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the delirium with CAM (Confusion Assessment Method that has NO unit) in PACU at 15 minutes after arrival in PACU (post-anesthesia care unit)</measure>
    <time_frame>15 minutes after arrival in PACU</time_frame>
    <description>To evaluate the CAM (no unit) in PACU at 15minutes after arrival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the delirium with CAM (Confusion Assessment Method that has NO unit) in PACU at 45 minutes after arrival in PACU (post-anesthesia care unit)</measure>
    <time_frame>45 minutes after arrival in PACU</time_frame>
    <description>To evaluate the CAM (no unit) in PACU at 45minutes after arrival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the total time spent in PACU in minutes</measure>
    <time_frame>3 hours after surgery</time_frame>
    <description>Total time in PACU in minutes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Bolus Versus Infusion Ketamine, Anesthesia Gas Consumption</condition>
  <arm_group>
    <arm_group_label>bolus of intravenous ketamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A bolus of 0.25mg.kg-1 of ketamine will be first administered at the time of incision (T0) then every single hour for the rest of the surgery. Study starts at incision (T0) for ketamine administration and ends when the surgical team starts closing the deep layers of the abdominal incision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>continuous infusion of intravenous ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An infusion of 0.25 mg.kg-1.h-1 is started at T0 (incision) with an infusion pump and is kept at the same rate until the surgical team starts closing the deep layers of the abdominal incision. Consumption of the infusion pump is noted at T0 (incision) and at each hour during the surgery until the infusion is discontinued.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bolus of intravenous ketamine</intervention_name>
    <description>low-dose ketamine (0.25mg.kg-1) is administered intraoperatively as bolus at incision (T0) and for each hour of anesthesia untel the end of surgery.</description>
    <arm_group_label>bolus of intravenous ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>continuous infusion of intravenous ketamine</intervention_name>
    <description>An infusion of low-dose ketamine (0.25 mg.kg-1.h-1) is started at T0 (incision) with an infusion pump and is kept at the same rate until the end of surgery</description>
    <arm_group_label>continuous infusion of intravenous ketamine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I to III&#xD;
&#xD;
          -  Patients above 18yo&#xD;
&#xD;
          -  Gender female or male&#xD;
&#xD;
          -  Abdominal general, urological or gynecological surgery with epidural placement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &lt;18 or &gt;35&#xD;
&#xD;
          -  Chronic neurological or psychiatric disorder or history of stroke&#xD;
&#xD;
          -  Use of psychotropic drugs within 2 weeks prior surgery&#xD;
&#xD;
          -  Allergy to ketamine or its excipients or any drug of the anesthesia protocol of this&#xD;
             study&#xD;
&#xD;
          -  Any contra-indication or patient's refusal for epidural placement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe PR Richebé, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CIUSSS Est de l'ile de Montreal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal</name>
      <address>
        <city>Montréal-Est</city>
        <state>Quebec</state>
        <zip>H1T2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ciusss de L'Est de l'Île de Montréal</investigator_affiliation>
    <investigator_full_name>Philippe Richebe</investigator_full_name>
    <investigator_title>MD, PhD, Professor, Director of Research, Department of Anesthesiology and Pain Medicine of Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL)</investigator_title>
  </responsible_party>
  <keyword>Ketamine</keyword>
  <keyword>anesthesia</keyword>
  <keyword>BIS monitoring</keyword>
  <keyword>epidural</keyword>
  <keyword>intraoperative</keyword>
  <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/NCT03781635
org study id: 2018-1482
nct id: NCT03781635
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the present study is to show that i.v. ketamine boluses might lead to significant
      and clinically relevant BIS index increase that might lead to an increase in anesthesia
      dosing (halogenous gas) when compared to an i.v. continuous infusion of ketamine without any
      bolus.
Hypothesis: The investigators hypothesize that BIS will not vary when ketamine is given as an
      i.v. infusion whereas BIS index will significantly vary when ketamine is given as
      intraoperative repeated bolus on an hourly basis. As a consequence, the bolus group might
      have a higher consumption of halogenous gases to keep BIS within normal values during
      anesthesia.

      Background: ketamine is a pure NMDA-receptor antagonist widely used in anesthesia for its
      anesthetic and analgesic properties. However, boluses of intravenous ketamine have been
      reported to increase BIS values. The present study is the first to compare ketamine effect on
      BIS values when given as an infusion versus repeated boluses.

      Objectives: primary objective: to measure the changes in BIS index values (delta BIS) after
      each bolus of i.v. ketamine 0.25mg.kg-1 given during anesthesia for surgeries lasting more
      than 3hs, and to demonstrate a significant increase of this BIS index whereas no significant
      increase is expected when i.v. ketamine is given as a continuous infusion intraoperatively.
      Secondary objectives: to measure the changes of BIS index values area under the curve when an
      infusion of i.v. ketamine 0.25mg.kg-1.h-1 is administered to the patient instead of boluses;
      to evaluate the time in minutes for the BIS index values to return within +/-10% of the
      pre-bolus values of this BIS index; to evaluate the time in seconds at which the peak of BIS
      will occur after ketamine bolus; to evaluate the consumption of halogenous gases during the
      entire surgery and for each hour of anesthesia (T0 = incision = time for first bolus of
      ketamine or start of ketamine infusion); to evaluate hemodynamic data (all the data from the
      ventilator and the monitor are recorded and exported per second) in both groups and see if
      the infusion group shows less hypotension events needing treatment with i.v. phenylephrine to
      stay within +/-20% of the mean blood pressure baseline; to evaluate the time for awakening,
      time for extubation, time spent in post-anesthesia care unit (PACU), delirium and cognitive
      functions in PACU (CAMshort assessment and MOCA).

      Methods: REB from CR-HMR will be obtained. 50 patients undergoing elective general,
      urological, gynecological surgeries will be explained the study at the pre-anesthesia
      consultation and then fully consented the day of the surgery. Anesthesia protocol will be
      fully standardized in both the groups. BIS monitoring will be installed before induction of
      general anesthesia as well as the standard anesthesia monitoring. Randomization into group
      infusion versus boluses of ketamine will be done prior to the entrance in the OR, the day of
      the surgery. Ketamine will be given as follows: in the i.v. ketamine infusion group, an
      infusion of 0.25 mg.kg-1.h-1 is started with an infusion pump and is kept at the same rate
      until the surgical team starts closing the deep layers of the abdominal incision. Consumption
      of the infusion pump is noted at T0 (incision) and at each hour during the surgery and when
      the infusion is discontinued. In the i.v. ketamine bolus group, 0.25mg.kg-1 of ketamine will
      be first administered at the time of incision (T0) then every single hour for the rest of the
      surgery. Study starts at anesthesia induction and incision (T0) for ketamine administration
      and ends when the patient leaves the PACU. Objectives of the study are cited above.

      Data analysis: statistical analyses will be done using SAS version 9.4 or higher and will be
      performed at a two-sided 0.05 significance level.

      Significance/Importance: This is the first study that will compare the impact of the
      classical intraoperative ketamine administered as repeated i.v. boluses versus as a
      continuous i.v. infusion during major surgeries lasting more than 3 hours.

      Study Design: open label study, with two controlled randomized parallel groups

      Subject Population: ASA 1 to 3 adult patients scheduled to undergo elective general, urologic
      or gynecological surgeries.

      Sample Size: 50 patients will be evaluated in this study.

      Study Duration: 10 months.

      Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal, Montreal,
      Quebec, Canada.

      Adverse Events: None expected.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups of patients. Randomization into group infusion versus boluses of ketamine according to a randomization list for a total number of patients of 50.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Randomization into group infusion versus boluses of ketamine will be done prior to the entrance in the OR, the day of the surgery
measure: Evaluation of the increase of the BIS index (absolute value between 0 to 100) after each intravenous ketamine bolus
time frame: Intraoperative, during anesthesia
description: To demonstrate and quantify à significant increase of the BIS index after each bolus of 0.25 mg.kg-1 ketamine given during surgeries lasting 3 hours and more, compared to an equivalent dose of ketamine given as a continuous infusion. Boluses of ketamine will start at T0 = incision and then will be repeated every hour for the duration of the surgery.
measure: Area under the curve of BIS values from T0=incision until end of the anesthesia, value without unit (area under curve)
time frame: Intraoperative, during anesthesia
description: To compare the BIS index values area under the curve from T0=incision until end of anesthesia when i.v. ketamine 0.25mg.kg-1.h-1 is administered as an infusion or as hourly boluses.
measure: Time for BIS to return within 10% of the baseline values (in minutes)
time frame: Intraoperative, during anesthesia
description: To evaluate the time in minutes for the BIS index values to return within +/-10% of the values the BIS index had before the bolus of ketamine.
measure: Time to reach the peak of BIS index after intravenous bolus of ketamine
time frame: Intraoperative, during anesthesia
description: To evaluate the time in seconds at which the peak of BIS will occur after intravenous ketamine bolus 0.25mg/kg.
measure: Evaluation of the consumption of halogenous gases (desflurane) during each hour of anesthesia in ml/kg/h of gas
time frame: Intraoperative, during anesthesia
description: To evaluate the consumption of halogenous gases (desflurane) during each hour of anesthesia in ml/kg/h.
measure: Evaluation of the consumption of phenylephrine in mcg/kg/h for each hour of anesthesia.
time frame: Intraoperative, during anesthesia
description: To evaluate the need of intravenous phenylephrine given during each hour of anesthesia in both groups.
measure: Evaluation of the blood pressure during each hour of anesthesia.
time frame: Intraoperative, during anesthesia
description: To evaluate blood pressure recorded electronically during the whole anesthesia and to evaluate the impact of intravenous bolus of ketamine 0.25mg/kg on blood pressure during the whole hour following each bolus administration (given hourly).
measure: Evaluation of the time in minutes necessary to extubatne the patient at the end of the surgery
time frame: End of surgery
description: To evaluate the time for extubation in minutes at the end of surgery
measure: Evaluation of the time in minutes to reach an Alerte score of >9 in post-anesthesia care unit
time frame: In post anesthesia care unit, 2 hours after surgery is done
description: To evaluate the time in minutes to reach an alerte score (this score has no unit) of more than 9.
measure: Evaluation of the MOCA score (score from 0 to 30) in PACU at 15 minutes after arrival in PACU (post-anesthesia care unit)
time frame: 15 minutes after arrival in PACU
description: To evaluate the MOCA score (0 to 30) in PACU at 15minutes after arrival.
measure: Evaluation of the MOCA score (score from 0 to 30) in PACU at 45 minutes after arrival in PACU (post-anesthesia care unit)
time frame: 45 minutes after arrival in PACU
description: To evaluate the MOCA score (0 to 30) in PACU at 45minutes after arrival.
measure: Evaluation of the delirium with CAM (Confusion Assessment Method that has NO unit) in PACU at 15 minutes after arrival in PACU (post-anesthesia care unit)
time frame: 15 minutes after arrival in PACU
description: To evaluate the CAM (no unit) in PACU at 15minutes after arrival.
measure: Evaluation of the delirium with CAM (Confusion Assessment Method that has NO unit) in PACU at 45 minutes after arrival in PACU (post-anesthesia care unit)
time frame: 45 minutes after arrival in PACU
description: To evaluate the CAM (no unit) in PACU at 45minutes after arrival.
measure: Evaluation of the total time spent in PACU in minutes
time frame: 3 hours after surgery
description: Total time in PACU in minutes
arm group label: bolus of intravenous ketamine
arm group type: Active Comparator
description: A bolus of 0.25mg.kg-1 of ketamine will be first administered at the time of incision (T0) then every single hour for the rest of the surgery. Study starts at incision (T0) for ketamine administration and ends when the surgical team starts closing the deep layers of the abdominal incision.
arm group label: continuous infusion of intravenous ketamine
arm group type: Experimental
description: An infusion of 0.25 mg.kg-1.h-1 is started at T0 (incision) with an infusion pump and is kept at the same rate until the surgical team starts closing the deep layers of the abdominal incision. Consumption of the infusion pump is noted at T0 (incision) and at each hour during the surgery until the infusion is discontinued.
intervention type: Drug
intervention name: bolus of intravenous ketamine
description: low-dose ketamine (0.25mg.kg-1) is administered intraoperatively as bolus at incision (T0) and for each hour of anesthesia untel the end of surgery.
arm group label: bolus of intravenous ketamine
intervention type: Drug
intervention name: continuous infusion of intravenous ketamine
description: An infusion of low-dose ketamine (0.25 mg.kg-1.h-1) is started at T0 (incision) with an infusion pump and is kept at the same rate until the end of surgery
arm group label: continuous infusion of intravenous ketamine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe PR Richebé, MD PhD
role: Principal Investigator
affiliation: CIUSSS Est de l'ile de Montreal
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Ciusss de L'Est de l'Île de Montréal
investigator full name: Philippe Richebe
investigator title: MD, PhD, Professor, Director of Research, Department of Anesthesiology and Pain Medicine of Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL)
mesh term: Ketamine