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/NCT05993975</url>
    </required_header>
    <id_info>
      <org_study_id>SAbbas</org_study_id>
      <nct_id>NCT05993975</nct_id>
    </id_info>
    <brief_title>Effects of Intrathecal Dexmedetomidine as an Adjuvant to Low Dose Hyperbaric 0.5% Bupivacaine</brief_title>
    <official_title>Effects of Intrathecal Dexmedetomidine as an Adjuvant to Low Dose Hyperbaric 0.5% Bupivacaine on Hemodynamic Parameters in Patients Undergoing Transurethral Resection of the Prostate</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sindh Institute of Urology and Transplantation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sindh Institute of Urology and Transplantation</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Patients will be enrolled in one of the two groups using a computer-generated random number&#xD;
        table: Group I will receive 2.5 ml of 0.5% hyperbaric bupivacaine (12.5 mg) . Group II will&#xD;
        receive 1.5 mL of 0.5% hyperbaric bupivacaine (7.5 mg) along with 1 mL (5 μg )of&#xD;
        dexmedetomidine (total 2.5 mL).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After approval of the synopsis and permission from the hospital ethics committee, all&#xD;
        patients meeting the inclusion criteria will be included in the study. Patients will be&#xD;
        instructed not to consume solid food after midnight before surgery and to take clear liquids&#xD;
        up to 2 hours before surgery. Using a computer-generated random number table, patients will&#xD;
        be enrolled in one of the two groups: Group I will receive 2.5 ml of 0.5% hyperbaric&#xD;
        bupivacaine (12.5 mg). Group II will receive 1.5 mL of 0.5% hyperbaric bupivacaine (7.5 mg)&#xD;
        along with 1 mL (5 μg )of dexmedetomidine (total 2.5 mL). They will be randomly allocated&#xD;
        into two groups using the sealed envelope technique by a person blinded to the procedure. The&#xD;
        study medication will be prepared by an anaesthesiologist not involved in the study and&#xD;
        another anaesthesiologist performing the spinal block will record the intraoperative and&#xD;
        postoperative data. On arrival at the Operating Room (OR) monitors like a non-invasive blood&#xD;
        pressure monitor (NIBP), peripheral oxygen saturation monitor (SpO2), and electrocardiography&#xD;
        monitor (ECG) having lead II will be attached. All the baseline values of blood pressure&#xD;
        (SBP, DBP, and MAP), heart rate and rhythm, and SPO2 will be observed and recorded. An&#xD;
        intravenous (IV) line will be established with an 18-gauge cannula. The study drug solutions&#xD;
        will look identical. For Group I, 12.5 mg(2.5 mL) of 0.5% hyperbaric bupivacaine&#xD;
        hydrochloride will be drawn in a 3 mL BD syringe. For Group II, 7.5mg (1.5 mL) of 0.5%&#xD;
        hyperbaric bupivacaine hydrochloride will be drawn in a 3 mL BD syringe. Dexmedetomidine&#xD;
        (preservative free) 100 μg/mL will be diluted with normal saline to 5 μg/mL in a 20 mL&#xD;
        syringe. From this diluted mixture, 1 mL (5μg )of dexmedetomidine will be drawn with the help&#xD;
        of a 3 mL BD syringe and will be added to the 7.5 mg (1.5 mL) of hyperbaric bupivacaine under&#xD;
        complete aseptic conditions to bring the total volume to 2.5 mL. The total volume of drug&#xD;
        solutions will be 2.5 mL in each group.&#xD;
  &#xD;
        Local infiltration of the skin with 2mL of 2% lidocaine will be done to decrease the&#xD;
        discomfort caused by the spinal needle. A spinal puncture will be performed at L3-L4 or L4-L5&#xD;
        with a midline approach using a 25-gauge Quincke needle in the sitting position. After&#xD;
        verification of clear and free flow of cerebrospinal fluid, the drug will be administered and&#xD;
        the patients will be placed in the supine position Vitals will be monitored Heart Rate (HR),&#xD;
        systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP),&#xD;
        respiratory rate (RR), oxygen saturation (SpO2) for every 5 minutes till the end of surgery.&#xD;
        If mean arterial pressure (MAP) decreases below 65 mmHg or the Heart rate falls below 65&#xD;
        beats per minute then intravenous vasopressors will be given. The sensory block levels will&#xD;
        be checked on the bilateral mid-clavicular line with a pin prick with a blunt needle every 2&#xD;
        min from the time of drug injection until the sensory level achieves up to T10 level. In&#xD;
        contrast, the motor block will be assessed using the modified Bromage scale. The surgeon will&#xD;
        be asked to start the surgery when the sensory block has reached to T10 level. After&#xD;
        completion of the surgery, the patient will be shifted to the PACU and will be monitored for&#xD;
        3 hours with continuous ECG monitoring and with intermittent non-invasive blood pressure&#xD;
        monitoring at 5 minutes intervals. All untoward events like shivering, nausea vomiting,&#xD;
        sedation, and respiratory depression will be monitored and recorded in the operating room as&#xD;
        well as in the recovery room.&#xD;
  &#xD;
        All data will be recorded on Performa attached as Annex A after the consultant anesthetist&#xD;
        confirms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 20, 2021</start_date>
    <completion_date type="Actual">February 18, 2022</completion_date>
    <primary_completion_date type="Actual">February 18, 2022</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>Group BUP will receive 2.5 ml of hyperbaric 0.5% bupivacaine (2.5 ml/12.5 mg) whereas the BUPIDEX group will receive Dexmedetomidine 5 micrograms with hyperbaric 0.5% bupivacaine (1.5 ml/7.5 mg) to be given to one group.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Height of sensory block</measure>
      <time_frame>0 to 4 hours</time_frame>
      <description>Dermatome level having absence of cold sensation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Motor block</measure>
      <time_frame>0 to 4 hours</time_frame>
      <description>According to Bromage scores&#xD;
  Grade Criteria I Free movement of legs and feet II Just able to flex knees with free movement of feet III Unable to flex knees, but with free movement of feet IV Unable to move legs or feet&#xD;
  we need paralysis of both legs (Bromage score IV) for surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time for 2 segment regression of sensory block</measure>
      <time_frame>0 to 4 hours</time_frame>
      <description>Dermatome level having absence of cold sensation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate</measure>
      <time_frame>0 to 4 hours</time_frame>
      <description>By anaesthesia ECG monitor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean Blood pressure</measure>
      <time_frame>0 to 4 hours</time_frame>
      <description>Non invasive blood pressure monitoring devise</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">108</enrollment>
    <condition>Post Operative Pain</condition>
    <arm_group>
      <arm_group_label>Bupivacaine 0.5%</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Hyperbaric Bupivacaine 0.5% (2.5 ml/12.5 mg) to be given intrathecally&#xD;
  Total volume 2.5 mL</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BUPI-DEX</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Hyperbaric Bupivacaine 0.5% (1.5 ml/7.5 mg)+Dexmedetomidine (1 mL) 5 microgram intrathecally.&#xD;
  Total volume 2.5 mL</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacain 0.5%</intervention_name>
      <description>Bupivacaine hydrochloride was given without any adjuvant</description>
      <arm_group_label>BUPI-DEX</arm_group_label>
      <arm_group_label>Bupivacaine 0.5%</arm_group_label>
      <other_name>Pure Bupivacain 0.5%</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexmedetomidine Hydrochloride</intervention_name>
      <description>Use of Dexmedetomidine Hydrochloride 5 micrograms (1 mL) as an adjuvant with bupivacaine hydrochloride</description>
      <arm_group_label>BUPI-DEX</arm_group_label>
      <other_name>Dexmedetomidine 5 microgram</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA I to ASA II&#xD;
  &#xD;
            -  Age 50 to 80 years old&#xD;
  &#xD;
            -  Height between 155cm and 175 cm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of spine surgery or the presence of an infectious focus on the back&#xD;
  &#xD;
            -  Patient's refusal to undergo a spinal anaesthesia&#xD;
  &#xD;
            -  Hypersensitivity to bupivacaine or dexmedetomidine&#xD;
  &#xD;
            -  Patients taking drugs of abuse or narcotic analgesics&#xD;
  &#xD;
            -  Diabetic neuropathy&#xD;
  &#xD;
            -  History of bleeding disorders&#xD;
  &#xD;
            -  Oral/intravenous anticoagulant therapy&#xD;
  &#xD;
            -  History of arrhythmias or labile hypertension&#xD;
  &#xD;
            -  Unco-operative patients&#xD;
  &#xD;
            -  Hearing defect&#xD;
  &#xD;
            -  ASA III and IV&#xD;
  &#xD;
            -  Central or peripheral nervous system disorders&#xD;
  &#xD;
            -  Severe hypovolemia&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Male patients coming for transurethral resection of the prostate</gender_description>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ali A Lanewala, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Sindh Institute of Urology &amp; Transplantation</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Syed Muhammad Abbas</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <zip>74200</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sindh Institute of Urology and Transplantation</investigator_affiliation>
      <investigator_full_name>Syed Muhammad Abbas</investigator_full_name>
      <investigator_title>Associate Professor, Department of Anaesthesia</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05993975
  org study id: SAbbas
  nct id: NCT05993975
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Patients will be enrolled in one of the two groups using a computer-generated random number
        table: Group I will receive 2.5 ml of 0.5% hyperbaric bupivacaine (12.5 mg) . Group II will
        receive 1.5 mL of 0.5% hyperbaric bupivacaine (7.5 mg) along with 1 mL (5 μg )of
        dexmedetomidine (total 2.5 mL).
  After approval of the synopsis and permission from the hospital ethics committee, all
        patients meeting the inclusion criteria will be included in the study. Patients will be
        instructed not to consume solid food after midnight before surgery and to take clear liquids
        up to 2 hours before surgery. Using a computer-generated random number table, patients will
        be enrolled in one of the two groups: Group I will receive 2.5 ml of 0.5% hyperbaric
        bupivacaine (12.5 mg). Group II will receive 1.5 mL of 0.5% hyperbaric bupivacaine (7.5 mg)
        along with 1 mL (5 μg )of dexmedetomidine (total 2.5 mL). They will be randomly allocated
        into two groups using the sealed envelope technique by a person blinded to the procedure. The
        study medication will be prepared by an anaesthesiologist not involved in the study and
        another anaesthesiologist performing the spinal block will record the intraoperative and
        postoperative data. On arrival at the Operating Room (OR) monitors like a non-invasive blood
        pressure monitor (NIBP), peripheral oxygen saturation monitor (SpO2), and electrocardiography
        monitor (ECG) having lead II will be attached. All the baseline values of blood pressure
        (SBP, DBP, and MAP), heart rate and rhythm, and SPO2 will be observed and recorded. An
        intravenous (IV) line will be established with an 18-gauge cannula. The study drug solutions
        will look identical. For Group I, 12.5 mg(2.5 mL) of 0.5% hyperbaric bupivacaine
        hydrochloride will be drawn in a 3 mL BD syringe. For Group II, 7.5mg (1.5 mL) of 0.5%
        hyperbaric bupivacaine hydrochloride will be drawn in a 3 mL BD syringe. Dexmedetomidine
        (preservative free) 100 μg/mL will be diluted with normal saline to 5 μg/mL in a 20 mL
        syringe. From this diluted mixture, 1 mL (5μg )of dexmedetomidine will be drawn with the help
        of a 3 mL BD syringe and will be added to the 7.5 mg (1.5 mL) of hyperbaric bupivacaine under
        complete aseptic conditions to bring the total volume to 2.5 mL. The total volume of drug
        solutions will be 2.5 mL in each group.
  
        Local infiltration of the skin with 2mL of 2% lidocaine will be done to decrease the
        discomfort caused by the spinal needle. A spinal puncture will be performed at L3-L4 or L4-L5
        with a midline approach using a 25-gauge Quincke needle in the sitting position. After
        verification of clear and free flow of cerebrospinal fluid, the drug will be administered and
        the patients will be placed in the supine position Vitals will be monitored Heart Rate (HR),
        systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP),
        respiratory rate (RR), oxygen saturation (SpO2) for every 5 minutes till the end of surgery.
        If mean arterial pressure (MAP) decreases below 65 mmHg or the Heart rate falls below 65
        beats per minute then intravenous vasopressors will be given. The sensory block levels will
        be checked on the bilateral mid-clavicular line with a pin prick with a blunt needle every 2
        min from the time of drug injection until the sensory level achieves up to T10 level. In
        contrast, the motor block will be assessed using the modified Bromage scale. The surgeon will
        be asked to start the surgery when the sensory block has reached to T10 level. After
        completion of the surgery, the patient will be shifted to the PACU and will be monitored for
        3 hours with continuous ECG monitoring and with intermittent non-invasive blood pressure
        monitoring at 5 minutes intervals. All untoward events like shivering, nausea vomiting,
        sedation, and respiratory depression will be monitored and recorded in the operating room as
        well as in the recovery room.
  
        All data will be recorded on Performa attached as Annex A after the consultant anesthetist
        confirms.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Group BUP will receive 2.5 ml of hyperbaric 0.5% bupivacaine (2.5 ml/12.5 mg) whereas the BUPIDEX group will receive Dexmedetomidine 5 micrograms with hyperbaric 0.5% bupivacaine (1.5 ml/7.5 mg) to be given to one group.
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  measure: Height of sensory block
  time frame: 0 to 4 hours
  description: Dermatome level having absence of cold sensation
  measure: Motor block
  time frame: 0 to 4 hours
  description: According to Bromage scores
  Grade Criteria I Free movement of legs and feet II Just able to flex knees with free movement of feet III Unable to flex knees, but with free movement of feet IV Unable to move legs or feet
  we need paralysis of both legs (Bromage score IV) for surgery
  measure: Time for 2 segment regression of sensory block
  time frame: 0 to 4 hours
  description: Dermatome level having absence of cold sensation
  measure: Heart rate
  time frame: 0 to 4 hours
  description: By anaesthesia ECG monitor
  measure: Mean Blood pressure
  time frame: 0 to 4 hours
  description: Non invasive blood pressure monitoring devise
  arm group label: Bupivacaine 0.5%
  arm group type: Active Comparator
  description: Hyperbaric Bupivacaine 0.5% (2.5 ml/12.5 mg) to be given intrathecally
  Total volume 2.5 mL
  arm group label: BUPI-DEX
  arm group type: Experimental
  description: Hyperbaric Bupivacaine 0.5% (1.5 ml/7.5 mg)+Dexmedetomidine (1 mL) 5 microgram intrathecally.
  Total volume 2.5 mL
  intervention type: Drug
  intervention name: Bupivacain 0.5%
  description: Bupivacaine hydrochloride was given without any adjuvant
  arm group label: BUPI-DEX
  arm group label: Bupivacaine 0.5%
  other name: Pure Bupivacain 0.5%
  intervention type: Drug
  intervention name: Dexmedetomidine Hydrochloride
  description: Use of Dexmedetomidine Hydrochloride 5 micrograms (1 mL) as an adjuvant with bupivacaine hydrochloride
  arm group label: BUPI-DEX
  other name: Dexmedetomidine 5 microgram
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Male patients coming for transurethral resection of the prostate
  minimum age: 50 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ali A Lanewala, MD, PhD
  role: Study Director
  affiliation: Sindh Institute of Urology & Transplantation
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Sindh Institute of Urology and Transplantation
  investigator full name: Syed Muhammad Abbas
  investigator title: Associate Professor, Department of Anaesthesia
  mesh term: Pain, Postoperative
  mesh term: Dexmedetomidine
  mesh term: Bupivacaine
  sharing ipd: No