<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/NCT03812718</url>
  </required_header>
  <id_info>
    <org_study_id>EC/01/19/1464</org_study_id>
    <nct_id>NCT03812718</nct_id>
  </id_info>
  <brief_title>Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway</brief_title>
  <official_title>Anaesthesia Requirements for Ventilation With Endotracheal Tube Versus ProSeal Laryngeal Mask Airway During Automated Feedback-Loop Controlled Total Intravenous Anaesthesia in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sir Ganga Ram Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sir Ganga Ram Hospital</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>
      Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation&#xD;
      during general anaesthesia (GA). however, the supra-glottic airway (SGA) devices in&#xD;
      particular the laryngeal mask airway (LMA) and its variants have become a reliable&#xD;
      alternative to ETT for carrying out controlled ventilation. Of the several variants of LMA&#xD;
      available today, the proseal LMA (PLMA) is preferred for controlled ventilation. The various&#xD;
      advantages of LMA includes, a lower incidence of postoperative sore throat and superior&#xD;
      haemodynamic profile during surgery. However, one aspect of providing anaesthesia with LMA&#xD;
      compared to ETT is the ability of LMA to maintain equivalent depth of anaesthesia with lower&#xD;
      anaesthetic requirement, is quiet intriguing and evidence to this regard is very limited.&#xD;
&#xD;
      By measuring the anaesthesia requirement using a robust computerised delivery system such as&#xD;
      the closed loop anaesthesia delivery system (CLADS) we can establish for sure the anaesthesia&#xD;
      required for maintaining intraoperative mechanical ventilation with the use of these two (ETT&#xD;
      and PLMA) airway management devices.&#xD;
&#xD;
      This randomised controlled study aims to calculate the anaesthesia requirement as determined&#xD;
      by the total amount of propofol consumed for maintaining anaesthesia with ETT versus PLMA&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation&#xD;
      during general anesthesia (GA). However, since the introduction of classic laryngeal mask&#xD;
      airway (LMA) in the 1980's and serial evolution of supra-glottic airway devices (SGA)&#xD;
      thereafter, LMAs have become a reliable alternative to ETT for carrying out controlled&#xD;
      ventilation. Interestingly, of the additional advantages that the LMA proffers, including, a&#xD;
      lower incidence of postoperative sore throat (POST) and superior hemodyamic profile during&#xD;
      surgery; its ability to maintain equivalent depth of anesthesia (in comparison to when&#xD;
      ETT-GA) with lower anesthetic requirement, is intriguing.&#xD;
&#xD;
      A handful of studies have demonstrated that the end-tidal isoflurane concentration required&#xD;
      for maintenance of GA is 0.2 -0.53% greater with use of ETT as compared to LMA. However, the&#xD;
      evidence generated by these studies remains unsubstantiated because in them, anaesthetic gas&#xD;
      concentration was titrated to patient's clinical profile like heart rate and blood pressure&#xD;
      without the backing of specific protocol for maintaining depth-of-anaesthesia. Therefore, for&#xD;
      credible evidence, assessment of quantitative anesthetic requirement for achieving and&#xD;
      sustaining a steady anesthesia depth with either LMA or ETT warrants confirmation with the&#xD;
      use of an objective depth-of-anesthesia monitor, such as, bispectral index (BIS).&#xD;
&#xD;
      Closed loop anaesthesia delivery system (CLADS) is an indigenously developed patented&#xD;
      (502/DEL/2003) computer-controlled and BIS-guided automated anesthesia delivery system.&#xD;
      CLADS, which runs on a control algorithm based on the relationship between diverse rates of&#xD;
      propofol infusion and the processed EEG variable; delivers propofol infusion at a rate which&#xD;
      is continuously adjusted by patient's state of depth of anesthesia as per BIS monitoring&#xD;
      input. This automated system maintains anaesthesia depth with high accuracy and objectively&#xD;
      determines propofol delivery quantitatively.&#xD;
&#xD;
      Of the several variants of SGA available today, the ProSeal laryngeal mask airway (PLMA) 9 is&#xD;
      preferred for controlled ventilation for its unique design that serves dual function of a&#xD;
      ventilation tube and an oropharyngeal drainage tube for excluding gastric contents from&#xD;
      getting aspirated through the peri-laryngeal cuff seal.&#xD;
&#xD;
      Given that CLADS can help us to accurately quantify anaesthesia, we hypothesize that there is&#xD;
      no difference in anesthesia requirement for GA maintained through an ETT or a PLMA. This&#xD;
      randomized controlled study aims to compare: anaesthesia requirement as determined by total&#xD;
      propofol consumption (primary objective); intraoperative hemodynamic profile and incidence of&#xD;
      POST (secondary objectives) in patients undergoing laparoscopic surgery with controlled&#xD;
      ventilation via ETT or PLMA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 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>160-patients will be randomly divided into one of the two groups:&#xD;
Group-I (ETT group, n= 80) ETT will be used as the airway device for maintaining ventilation&#xD;
Group-2 (PLMA group, n= 80) PLMA will be used as the airway device for maintaining ventilation</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The attending anaesthesiologist will not be blinded to the technique utilized to administer GA. An independent assessor unaware of the technique utilized for administering GA will analyse the intraoperative data and conduct the postoperative follow up</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Propofol usage in milligrams</measure>
    <time_frame>From beginning of anaesthesia (0-hours, baseline) till 4 hours intraoperatively</time_frame>
    <description>Comparison of quantitative difference in propofol requirement between the two groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anaesthesia depth consistency using BIS scores</measure>
    <time_frame>From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively</time_frame>
    <description>Determined by the percentage of the total anaesthesia time in which the BIS scores remain within a score of 10% of the target BIS (i.e. BIS-50) in both the study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of propofol anaesthesia delivery system</measure>
    <time_frame>From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively</time_frame>
    <description>Determined by using Varvel criteria parameters; median performance error (MDP), median absolute performance error (MDAPE), wobble and global score in both the study arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intra-operative heart Rate (beats per minute)</measure>
    <time_frame>From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively</time_frame>
    <description>Comparison of intra-operative heart rate between both the arms will be done</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intra-operative systolic , diastolic, and mean (mmHg)</measure>
    <time_frame>From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively</time_frame>
    <description>Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early Recovery from anesthesia</measure>
    <time_frame>From end of anaesthesia till 20-minutes postoperatively</time_frame>
    <description>Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative sedation</measure>
    <time_frame>From the end of anaesthesia till 24-hours, postoperatively</time_frame>
    <description>Will be assessed using Modified Observer's assessment of alertness/sedation scale (MOAA/S)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postoperative sore throat</measure>
    <time_frame>From the end of anaesthesia till 24-hours, postoperatively</time_frame>
    <description>Comparison of post operative sore throat occurrence between the two groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Cholelithiases</condition>
  <condition>Cholecystolithiasis</condition>
  <arm_group>
    <arm_group_label>ETT Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Anesthesia will be induced with fentanyl-citrate (3µg/kg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg/kg will be given to facilitate placement of airway device. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.&#xD;
Intraoperative ventilation will be instituted through a polyvinyl chloride (PVC) ETT (Portex, Smiths Medical ASD, Inc, Minneapolis, USA). The size of the tube will be standardized for the male (7.5 mm ID) and the female (6.5 MM ID).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLMA Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Anesthesia will be induced with fentanyl-citrate (3µg/kg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg/kg will be given to facilitate placement of airway device. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA. intraoperative ventilation will be maintained with PLMA (Telefex Medical, Westmeath Ireland) whose size would be selected based on body weight. In patients weighing 30-50 kg PLMA # 3.0, 50-70 kg PLMA # 4.0, and 50-100 kg PLMA # 5.0 will be inserted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endotracheal tube (ETT)</intervention_name>
    <description>After induction of anaesthesia patient will be intubated with polyvinyl chloride (PVC) ETT for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.</description>
    <arm_group_label>ETT Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProSeal Laryngeal Mask Airway (PLMA)</intervention_name>
    <description>After induction of anaesthesia ProSeal Laryngeal Mask Airway (PLMA) will be inserted for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.</description>
    <arm_group_label>PLMA Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA physical status I/II&#xD;
&#xD;
          2. Undergoing elective laparoscopic cholecystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anticipated difficult airway&#xD;
&#xD;
          2. Body mass index &gt; 30-kg/m2&#xD;
&#xD;
          3. Uncompensated cardiovascular disease (e.g. uncontrolled hypertension,&#xD;
             atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV&#xD;
             compliance, diastolic dysfunction)&#xD;
&#xD;
          4. Hepato-renal insufficiency&#xD;
&#xD;
          5. Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism)&#xD;
&#xD;
          6. Known allergy/hypersensitivity to the study drug (propofol)&#xD;
&#xD;
          7. Drug dependence/substance abuse/psychiatric illness&#xD;
&#xD;
          8. Requirement of postoperative ventilation&#xD;
&#xD;
          9. Refusal to informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nitin Sethi, DNB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sir Ganga Ram Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amitabh Dutta, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sir Ganga Ram Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jayashree Sood, MD, FFRCA</last_name>
    <role>Study Chair</role>
    <affiliation>Sir Ganga Ram Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nitin Sethi, DNB</last_name>
    <phone>00919717494498</phone>
    <email>nitinsethi77@yahoo.co.in</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amitabh Dutta, MD</last_name>
    <phone>+911142252523</phone>
    <email>duttaamiatbh@yahoo.co.in</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sir Ganga Ram Hospital</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nitin Sethi, DNB</last_name>
      <phone>+911142252523</phone>
      <email>nitinsethi77@yahoo.co.in</email>
    </contact>
    <contact_backup>
      <last_name>Amitabh Dutta, MD</last_name>
      <phone>+911142252523</phone>
      <email>duttaamiatbh@yahoo.co.in</email>
    </contact_backup>
    <investigator>
      <last_name>Nitin Sethi, DNB</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amitabh Dutta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Goverdhan D Puri, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jayashree Sood, MD,FFRCA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bhuwan C Panday, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Prabhat K Choudhary, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Manish Gupta, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Savitar Malhotra, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sir Ganga Ram Hospital</investigator_affiliation>
    <investigator_full_name>Nitin Sethi, DNB</investigator_full_name>
    <investigator_title>Consultant &amp; Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
    <mesh_term>Gallstones</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03812718
org study id: EC/01/19/1464
nct id: NCT03812718
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation
      during general anaesthesia (GA). however, the supra-glottic airway (SGA) devices in
      particular the laryngeal mask airway (LMA) and its variants have become a reliable
      alternative to ETT for carrying out controlled ventilation. Of the several variants of LMA
      available today, the proseal LMA (PLMA) is preferred for controlled ventilation. The various
      advantages of LMA includes, a lower incidence of postoperative sore throat and superior
      haemodynamic profile during surgery. However, one aspect of providing anaesthesia with LMA
      compared to ETT is the ability of LMA to maintain equivalent depth of anaesthesia with lower
      anaesthetic requirement, is quiet intriguing and evidence to this regard is very limited.

      By measuring the anaesthesia requirement using a robust computerised delivery system such as
      the closed loop anaesthesia delivery system (CLADS) we can establish for sure the anaesthesia
      required for maintaining intraoperative mechanical ventilation with the use of these two (ETT
      and PLMA) airway management devices.

      This randomised controlled study aims to calculate the anaesthesia requirement as determined
      by the total amount of propofol consumed for maintaining anaesthesia with ETT versus PLMA
Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation
      during general anesthesia (GA). However, since the introduction of classic laryngeal mask
      airway (LMA) in the 1980's and serial evolution of supra-glottic airway devices (SGA)
      thereafter, LMAs have become a reliable alternative to ETT for carrying out controlled
      ventilation. Interestingly, of the additional advantages that the LMA proffers, including, a
      lower incidence of postoperative sore throat (POST) and superior hemodyamic profile during
      surgery; its ability to maintain equivalent depth of anesthesia (in comparison to when
      ETT-GA) with lower anesthetic requirement, is intriguing.

      A handful of studies have demonstrated that the end-tidal isoflurane concentration required
      for maintenance of GA is 0.2 -0.53% greater with use of ETT as compared to LMA. However, the
      evidence generated by these studies remains unsubstantiated because in them, anaesthetic gas
      concentration was titrated to patient's clinical profile like heart rate and blood pressure
      without the backing of specific protocol for maintaining depth-of-anaesthesia. Therefore, for
      credible evidence, assessment of quantitative anesthetic requirement for achieving and
      sustaining a steady anesthesia depth with either LMA or ETT warrants confirmation with the
      use of an objective depth-of-anesthesia monitor, such as, bispectral index (BIS).

      Closed loop anaesthesia delivery system (CLADS) is an indigenously developed patented
      (502/DEL/2003) computer-controlled and BIS-guided automated anesthesia delivery system.
      CLADS, which runs on a control algorithm based on the relationship between diverse rates of
      propofol infusion and the processed EEG variable; delivers propofol infusion at a rate which
      is continuously adjusted by patient's state of depth of anesthesia as per BIS monitoring
      input. This automated system maintains anaesthesia depth with high accuracy and objectively
      determines propofol delivery quantitatively.

      Of the several variants of SGA available today, the ProSeal laryngeal mask airway (PLMA) 9 is
      preferred for controlled ventilation for its unique design that serves dual function of a
      ventilation tube and an oropharyngeal drainage tube for excluding gastric contents from
      getting aspirated through the peri-laryngeal cuff seal.

      Given that CLADS can help us to accurately quantify anaesthesia, we hypothesize that there is
      no difference in anesthesia requirement for GA maintained through an ETT or a PLMA. This
      randomized controlled study aims to compare: anaesthesia requirement as determined by total
      propofol consumption (primary objective); intraoperative hemodynamic profile and incidence of
      POST (secondary objectives) in patients undergoing laparoscopic surgery with controlled
      ventilation via ETT or PLMA.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 160-patients will be randomly divided into one of the two groups:
Group-I (ETT group, n= 80) ETT will be used as the airway device for maintaining ventilation
Group-2 (PLMA group, n= 80) PLMA will be used as the airway device for maintaining ventilation
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: The attending anaesthesiologist will not be blinded to the technique utilized to administer GA. An independent assessor unaware of the technique utilized for administering GA will analyse the intraoperative data and conduct the postoperative follow up
measure: Change in Propofol usage in milligrams
time frame: From beginning of anaesthesia (0-hours, baseline) till 4 hours intraoperatively
description: Comparison of quantitative difference in propofol requirement between the two groups
measure: Anaesthesia depth consistency using BIS scores
time frame: From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
description: Determined by the percentage of the total anaesthesia time in which the BIS scores remain within a score of 10% of the target BIS (i.e. BIS-50) in both the study arms.
measure: Evaluation of propofol anaesthesia delivery system
time frame: From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
description: Determined by using Varvel criteria parameters; median performance error (MDP), median absolute performance error (MDAPE), wobble and global score in both the study arms
measure: Change in Intra-operative heart Rate (beats per minute)
time frame: From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
description: Comparison of intra-operative heart rate between both the arms will be done
measure: Change in Intra-operative systolic , diastolic, and mean (mmHg)
time frame: From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively
description: Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done
measure: Early Recovery from anesthesia
time frame: From end of anaesthesia till 20-minutes postoperatively
description: Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted
measure: Post operative sedation
time frame: From the end of anaesthesia till 24-hours, postoperatively
description: Will be assessed using Modified Observer's assessment of alertness/sedation scale (MOAA/S)
measure: Incidence of postoperative sore throat
time frame: From the end of anaesthesia till 24-hours, postoperatively
description: Comparison of post operative sore throat occurrence between the two groups
arm group label: ETT Group
arm group type: Active Comparator
description: Anesthesia will be induced with fentanyl-citrate (3µg/kg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg/kg will be given to facilitate placement of airway device. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.
Intraoperative ventilation will be instituted through a polyvinyl chloride (PVC) ETT (Portex, Smiths Medical ASD, Inc, Minneapolis, USA). The size of the tube will be standardized for the male (7.5 mm ID) and the female (6.5 MM ID).
arm group label: PLMA Group
arm group type: Active Comparator
description: Anesthesia will be induced with fentanyl-citrate (3µg/kg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg/kg will be given to facilitate placement of airway device. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA. intraoperative ventilation will be maintained with PLMA (Telefex Medical, Westmeath Ireland) whose size would be selected based on body weight. In patients weighing 30-50 kg PLMA # 3.0, 50-70 kg PLMA # 4.0, and 50-100 kg PLMA # 5.0 will be inserted.
intervention type: Device
intervention name: Endotracheal tube (ETT)
description: After induction of anaesthesia patient will be intubated with polyvinyl chloride (PVC) ETT for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.
arm group label: ETT Group
intervention type: Device
intervention name: ProSeal Laryngeal Mask Airway (PLMA)
description: After induction of anaesthesia ProSeal Laryngeal Mask Airway (PLMA) will be inserted for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.
arm group label: PLMA Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nitin Sethi, DNB
role: Principal Investigator
affiliation: Sir Ganga Ram Hospital
last name: Amitabh Dutta, MD
role: Study Director
affiliation: Sir Ganga Ram Hospital
last name: Jayashree Sood, MD, FFRCA
role: Study Chair
affiliation: Sir Ganga Ram Hospital
last name: Nitin Sethi, DNB
phone: 00919717494498
email: nitinsethi77@yahoo.co.in
last name: Amitabh Dutta, MD
phone: +911142252523
email: duttaamiatbh@yahoo.co.in
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Sir Ganga Ram Hospital
investigator full name: Nitin Sethi, DNB
investigator title: Consultant & Associate Professor
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Gallstones
sharing ipd: No