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/NCT06014957</url>
    </required_header>
    <id_info>
      <org_study_id>transurethral resection</org_study_id>
      <nct_id>NCT06014957</nct_id>
    </id_info>
    <brief_title>Comparison of Hemodynamic Effect Between the Spinal Anesthesia and Saddle Block Using Levobupivacaine During Transurethral Resection of the Prostate in Cardiac Elderly Patients</brief_title>
    <official_title>Comparison of Hemodynamic Effect Between the Spinal Anesthesia and Saddle Block Using Levobupivacaine During Transurethral Resection of the Prostate in Cardiac Elderly Patients: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>New Valley University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>New Valley University</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>
        Transurethral resection of the prostate (TURP) is the most common surgical intervention for&#xD;
        patients with benign prostatic hyperplasia. TURP is mostly applied to elderly patients with&#xD;
        hypertension and problems with breathing, circulation system, and kidney functions;&#xD;
        therefore, it becomes very important to keep a stable anesthesia that will minimize the&#xD;
        hemodynamic differences in these patients. General anesthesia causes more hemodynamic&#xD;
        differences than regional anesthesia. Thus, regional anesthesia is highly preferable in TURP&#xD;
        applications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        TURP is performed by inserting a resectoscope through the urethra and resecting prostatic&#xD;
        tissue with an electrically powered cutting-coagulating metal loop or using laser-22&#xD;
        vaporization energy. This can be accomplished with either a monopolar TURP (M-TURP) or&#xD;
        bipolar TURP (B-TURP) technique. Laser energy for TURP has also been used for many years.&#xD;
        With each technique, as much prostatic tissue as possible is resected, but the prostatic&#xD;
        capsule is usually preserved. If the capsule is violated, large amounts of irrigation&#xD;
        solution can be absorbed into the circulation via the periprostatic, retroperitoneal, or&#xD;
        peritoneal space. Bleeding during TURP is not uncommon but usually controllable; hemostasis&#xD;
        becomes difficult when large venous sinuses are opened. If the bleeding becomes&#xD;
        uncontrollable, the procedure should be terminated as quickly as possible, and a Foley&#xD;
        catheter should be passed into the bladder and traction applied to it. The catheter's&#xD;
        inflated balloon exerts lateral pressure on the prostatic bed and reduces bleeding. Bleeding&#xD;
        requiring transfusion occurs in approximately 2.5% of TURP procedures.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>mean arterial blood pressure</measure>
      <time_frame>24 hours</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>TURP Syndrome</condition>
    <condition>Spinal Anesthesia</condition>
    <arm_group>
      <arm_group_label>spinal group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF),immediately positioned supine with one pillow supporting the head and shoulders.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>saddle block group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF),placed in the sitting position for ten minutes and then supine with one pillow supporting the head and shoulders.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>spinal anesthesia</intervention_name>
      <description>12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF), immediately positioned supine with one pillow supporting the head and shoulders</description>
      <arm_group_label>spinal group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>saddle block</intervention_name>
      <description>12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF), placed in the sitting position for ten minutes and then supine with one pillow supporting the head and shoulders</description>
      <arm_group_label>saddle block group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) III,&#xD;
  &#xD;
            -  with Ischemic Heart Disease (history of Myocardial Ischemia,&#xD;
  &#xD;
            -  a history of a positive treadmill test result (Electro Cardio Graph stress test),&#xD;
  &#xD;
            -  use of nitroglycerin, chronic stable angina for more than two months, or an ECG with&#xD;
               abnormal Q waves), with ejection fraction (EF) 35%-50%,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients under 65 years,&#xD;
  &#xD;
            -  patients with any diseases that increase intraabdominal pressure (any intra-abdominal&#xD;
               mass),&#xD;
  &#xD;
            -  general contraindications of spinal anesthesia as patient refusal, coagulation&#xD;
               disorders, local infection at the site of the block, psychiatric illness,&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ahmed Twaisy, MD</last_name>
      <phone>01007410757</phone>
      <email>Twisy200235@med.nvu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ahmed Omar Twaisy</name>
        <address>
          <city>New Cairo</city>
          <state>Kharga</state>
          <zip>72713</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ahmed Twaisy, MD</last_name>
        <phone>01007410757</phone>
        <email>Twisy200235@med.nvu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Bhattacharyya S, Bisai S, Biswas H, Tiwary MK, Mallik S, Saha SM. Regional anesthesia in transurethral resection of prostate (TURP) surgery: A comparative study between saddle block and subarachnoid block. Saudi J Anaesth. 2015 Jul-Sep;9(3):268-71. doi: 10.4103/1658-354X.158497.</citation>
      <PMID>26240544</PMID>
    </reference>
    <reference>
      <citation>Rooke GA, Freund PR, Jacobson AF. Hemodynamic response and change in organ blood volume during spinal anesthesia in elderly men with cardiac disease. Anesth Analg. 1997 Jul;85(1):99-105. doi: 10.1097/00000539-199707000-00018.</citation>
      <PMID>9212130</PMID>
    </reference>
    <reference>
      <citation>Gulec D, Karsli B, Ertugrul F, Bigat Z, Kayacan N. Intrathecal bupivacaine or levobupivacaine: which should be used for elderly patients? J Int Med Res. 2014 Apr;42(2):376-85. doi: 10.1177/0300060513496737. Epub 2014 Mar 4.</citation>
      <PMID>24595149</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>New Valley University</investigator_affiliation>
      <investigator_full_name>Ahmed Omar Twaisy</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</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/NCT06014957
  org study id: transurethral resection
  nct id: NCT06014957
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Transurethral resection of the prostate (TURP) is the most common surgical intervention for
        patients with benign prostatic hyperplasia. TURP is mostly applied to elderly patients with
        hypertension and problems with breathing, circulation system, and kidney functions;
        therefore, it becomes very important to keep a stable anesthesia that will minimize the
        hemodynamic differences in these patients. General anesthesia causes more hemodynamic
        differences than regional anesthesia. Thus, regional anesthesia is highly preferable in TURP
        applications.
  TURP is performed by inserting a resectoscope through the urethra and resecting prostatic
        tissue with an electrically powered cutting-coagulating metal loop or using laser-22
        vaporization energy. This can be accomplished with either a monopolar TURP (M-TURP) or
        bipolar TURP (B-TURP) technique. Laser energy for TURP has also been used for many years.
        With each technique, as much prostatic tissue as possible is resected, but the prostatic
        capsule is usually preserved. If the capsule is violated, large amounts of irrigation
        solution can be absorbed into the circulation via the periprostatic, retroperitoneal, or
        peritoneal space. Bleeding during TURP is not uncommon but usually controllable; hemostasis
        becomes difficult when large venous sinuses are opened. If the bleeding becomes
        uncontrollable, the procedure should be terminated as quickly as possible, and a Foley
        catheter should be passed into the bladder and traction applied to it. The catheter's
        inflated balloon exerts lateral pressure on the prostatic bed and reduces bleeding. Bleeding
        requiring transfusion occurs in approximately 2.5% of TURP procedures.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: mean arterial blood pressure
  time frame: 24 hours
  arm group label: spinal group
  arm group type: Experimental
  description: 12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF),immediately positioned supine with one pillow supporting the head and shoulders.
  arm group label: saddle block group
  arm group type: Experimental
  description: 12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF),placed in the sitting position for ten minutes and then supine with one pillow supporting the head and shoulders.
  intervention type: Drug
  intervention name: spinal anesthesia
  description: 12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF), immediately positioned supine with one pillow supporting the head and shoulders
  arm group label: spinal group
  intervention type: Drug
  intervention name: saddle block
  description: 12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF), placed in the sitting position for ten minutes and then supine with one pillow supporting the head and shoulders
  arm group label: saddle block group
  criteria: 
  gender: Male
  minimum age: 65 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ahmed Twaisy, MD
  phone: 01007410757
  email: Twisy200235@med.nvu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Bhattacharyya S, Bisai S, Biswas H, Tiwary MK, Mallik S, Saha SM. Regional anesthesia in transurethral resection of prostate (TURP) surgery: A comparative study between saddle block and subarachnoid block. Saudi J Anaesth. 2015 Jul-Sep;9(3):268-71. doi: 10.4103/1658-354X.158497.
  PMID: 26240544
  citation: Rooke GA, Freund PR, Jacobson AF. Hemodynamic response and change in organ blood volume during spinal anesthesia in elderly men with cardiac disease. Anesth Analg. 1997 Jul;85(1):99-105. doi: 10.1097/00000539-199707000-00018.
  PMID: 9212130
  citation: Gulec D, Karsli B, Ertugrul F, Bigat Z, Kayacan N. Intrathecal bupivacaine or levobupivacaine: which should be used for elderly patients? J Int Med Res. 2014 Apr;42(2):376-85. doi: 10.1177/0300060513496737. Epub 2014 Mar 4.
  PMID: 24595149
  responsible party type: Principal Investigator
  investigator affiliation: New Valley University
  investigator full name: Ahmed Omar Twaisy
  investigator title: Principal investigator
  mesh term: Anesthetics
  sharing ipd: No