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/NCT05991466</url>
    </required_header>
    <id_info>
      <org_study_id>MD-172-2021</org_study_id>
      <nct_id>NCT05991466</nct_id>
    </id_info>
    <brief_title>Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections</brief_title>
    <official_title>The Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections: a Randomized Comparative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <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 study hypothesizes that addition of dexmedetomidine to bupivacaine either in spinal&#xD;
        anesthesia or TAP block is more effective and provide better ObsQor-11score than bupivacaine&#xD;
        alone. Also, Dexmedetomidine in TAP block might provide a longer pain free time in comparison&#xD;
        to intrathecal dexmedetomidine.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim of the work To compare the quality of recovery (ObsQOR-11) in patients undergoing&#xD;
        cesarean sections receiving dexmedetomedine either intrathecally or in the tap block in&#xD;
        comparison to patients receiving conventional spinal anesthesia and tap block.&#xD;
  &#xD;
        Statistical Analysis I. Sample size In a pilot study on 5 parturient who had undergone&#xD;
        elective cesarean section under spinal anesthesia followed by TAP block with bupivacaine&#xD;
        alone, the mean ObsQoR-11 at 24 hours was 65±9. In a single factor ANOVA study, sample size&#xD;
        of 126 from the 3 groups is needed to detect a difference of at least 10 using the&#xD;
        Tukey-Kramer (Pairwise) multiple comparison with study power of 83% and alpha error of 0.05.&#xD;
        The common standard deviation within a group is assumed to be 9. The number of envelopes will&#xD;
        be increased to 141 (47 per group) to compensate of possible 10% dropout. The sample size was&#xD;
        calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC.&#xD;
        Kaysville, Utah, USA, ncss.com/software/pass.&#xD;
  &#xD;
        II. Statistical analysis Data will be coded and entered using the statistical package SPSS&#xD;
        (statistical package for the social science) version 22. Data will be summarized using mean,&#xD;
        standard deviation, median, minimum and maximum in quantitative data and using frequency&#xD;
        (count) and relative frequency(percentage)for categorical data. Comparisons between&#xD;
        quantitative variables will be done using the non parametric Mann-Whitney test. For comparing&#xD;
        categorical data, Chi square (x2 ) test will be performed. Exact test will be used instead&#xD;
        when the expected frequency is less than 5. P-value less than 0.05 will be considered as&#xD;
        statistically significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Actual">December 31, 2022</completion_date>
    <primary_completion_date type="Actual">September 30, 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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of recovery score following CS (ObsQor-11) at the end of the first 24 hours postoperative.</measure>
      <time_frame>24 hours postoperative</time_frame>
      <description>The mothers will be asked to rate each recovery item with an 11-point numerical Likert scale (0 = strongly negative; 10 = strongly positive).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time of first request of analgesia in hours</measure>
      <time_frame>within 24 hours postoperative</time_frame>
      <description>from time of spinal anesthesia to the first registration of VAS score more than 3</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ramsay sedation scale</measure>
      <time_frame>1, 2, 4, 6, 8, 12 and 24 hours</time_frame>
      <description>Awake; agitated or restless or both&#xD;
  Awake; cooperative, oriented, and tranquil&#xD;
  Awake but responds to commands only&#xD;
  Asleep; brisk response to light glabellar tap or loud auditory stimulus&#xD;
  Asleep; sluggish response to light glabellar tap or loud auditory stimulus&#xD;
  Asleep; no response to glabellar tap or loud auditory stimulus</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intra operative non-invasive mean blood pressure</measure>
      <time_frame>within 24 hours postoperative</time_frame>
      <description>in mmhg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intra operative heart rate</measure>
      <time_frame>within 24 hours postoperative</time_frame>
      <description>beats per minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale</measure>
      <time_frame>1, 2, 4, 6, 8, 12 and 24 hours postoperative</time_frame>
      <description>VAS score at rest and during movement and cough The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nausea and vomiting</measure>
      <time_frame>intraoperative and postoperative 24 hours</time_frame>
      <description>Nausea and vomiting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Onset of motor block using Bromage scale</measure>
      <time_frame>Post spinal anesthesia up to 30 minutes</time_frame>
      <description>defined as the time from giving spinal anesthesia until a modified Bromage score of IV will be reached),Duration of motor block (defined as the time from spinal anesthesia until Modified Bromage score of I).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Onset of sensory block</measure>
      <time_frame>Post spinal anesthesia up to 30 minutes</time_frame>
      <description>defined as the time needed to lose cold sensation when using the ice-cold test at the T6 dermatome level) and time to 2-segment regression of spinal anesthesia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal Apgar score</measure>
      <time_frame>at 1 and 5 minutes post delivery</time_frame>
      <description>This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complications of spinal anaesthesia and TAP block</measure>
      <time_frame>12 hours post operative period.</time_frame>
      <description>Complications of spinal anaesthesia and TAP block</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of hypotension</measure>
      <time_frame>post spinal anesthesia up to 1 hour</time_frame>
      <description>systolic blood pressure &lt; 90 or &lt;70% of baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of bradycardia</measure>
      <time_frame>post spinal anesthesia up to 1 hour</time_frame>
      <description>heart rate less than 60 beats per minute</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">141</enrollment>
    <condition>The Quality of Recovery (ObsQOR-11)</condition>
    <arm_group>
      <arm_group_label>Group(A)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg and TAP block will be performed with 30 ml 0.25% bupivacaine in each side.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group (B)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine10-12 mg and TAP block will be performed with 50 mcg Dexmedetomidine added to 30ml 0.25% bupivacaine in each side.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group (C)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg added to 5 mcg dexmedetomidine. TAP block will be performed with 30ml 0.25% bupivacaine in each side.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexmedetomidine</intervention_name>
      <description>All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications. The required laboratory work will be: complete blood count (CBC); prothrombin time and concentration (PT&amp;PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT); liver function tests and kidney function tests.&#xD;
  Before arrival to the operation room (OR), women will be premedicated by metoclopramide 10mg and ranitidine 50 mg intravenous. Intra operatively, hemodynamics will be recorded baseline before spinal anaesthesia , after its performance, every 3 minutes until delivery and then every 10 minutes till the end of the CS. Any change within 20% of baseline will be accepted and any changes more than 20% will be managed according to guidelines. All groups will be anaesthetized to preform CS with conventional spinal anaesthesia. The TAP block group will receive a landmark orientated Ultrasound guided bilateral TAP block.</description>
      <arm_group_label>Group (B)</arm_group_label>
      <arm_group_label>Group (C)</arm_group_label>
      <arm_group_label>Group(A)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants will be full-term pregnant females&#xD;
  &#xD;
            -  ASA classification I or ll.&#xD;
  &#xD;
            -  Aged between 18 and 40 years.&#xD;
  &#xD;
            -  Singleton pregnancy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of block.&#xD;
  &#xD;
            -  Bleeding disorders (platelets count &lt;150,000; INR&gt;1.5; PC&lt;60%).&#xD;
  &#xD;
            -  wounds or infection at the puncture site.&#xD;
  &#xD;
            -  Known allergy to local anesthetic drugs.&#xD;
  &#xD;
            -  Contraindications to neuroaxial block.&#xD;
  &#xD;
            -  Contraindications to TAP block..&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Medicine, Cairo University</name>
        <address>
          <city>Cairo</city>
          <zip>11562</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Mohamed Ahmed Mohamed Youssef Ollaek</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</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/NCT05991466
  org study id: MD-172-2021
  nct id: NCT05991466
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The study hypothesizes that addition of dexmedetomidine to bupivacaine either in spinal
        anesthesia or TAP block is more effective and provide better ObsQor-11score than bupivacaine
        alone. Also, Dexmedetomidine in TAP block might provide a longer pain free time in comparison
        to intrathecal dexmedetomidine.
  Aim of the work To compare the quality of recovery (ObsQOR-11) in patients undergoing
        cesarean sections receiving dexmedetomedine either intrathecally or in the tap block in
        comparison to patients receiving conventional spinal anesthesia and tap block.
  
        Statistical Analysis I. Sample size In a pilot study on 5 parturient who had undergone
        elective cesarean section under spinal anesthesia followed by TAP block with bupivacaine
        alone, the mean ObsQoR-11 at 24 hours was 65±9. In a single factor ANOVA study, sample size
        of 126 from the 3 groups is needed to detect a difference of at least 10 using the
        Tukey-Kramer (Pairwise) multiple comparison with study power of 83% and alpha error of 0.05.
        The common standard deviation within a group is assumed to be 9. The number of envelopes will
        be increased to 141 (47 per group) to compensate of possible 10% dropout. The sample size was
        calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC.
        Kaysville, Utah, USA, ncss.com/software/pass.
  
        II. Statistical analysis Data will be coded and entered using the statistical package SPSS
        (statistical package for the social science) version 22. Data will be summarized using mean,
        standard deviation, median, minimum and maximum in quantitative data and using frequency
        (count) and relative frequency(percentage)for categorical data. Comparisons between
        quantitative variables will be done using the non parametric Mann-Whitney test. For comparing
        categorical data, Chi square (x2 ) test will be performed. Exact test will be used instead
        when the expected frequency is less than 5. P-value less than 0.05 will be considered as
        statistically significant.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Quality of recovery score following CS (ObsQor-11) at the end of the first 24 hours postoperative.
  time frame: 24 hours postoperative
  description: The mothers will be asked to rate each recovery item with an 11-point numerical Likert scale (0 = strongly negative; 10 = strongly positive).
  measure: Time of first request of analgesia in hours
  time frame: within 24 hours postoperative
  description: from time of spinal anesthesia to the first registration of VAS score more than 3
  measure: Ramsay sedation scale
  time frame: 1, 2, 4, 6, 8, 12 and 24 hours
  description: Awake; agitated or restless or both
  Awake; cooperative, oriented, and tranquil
  Awake but responds to commands only
  Asleep; brisk response to light glabellar tap or loud auditory stimulus
  Asleep; sluggish response to light glabellar tap or loud auditory stimulus
  Asleep; no response to glabellar tap or loud auditory stimulus
  measure: Intra operative non-invasive mean blood pressure
  time frame: within 24 hours postoperative
  description: in mmhg
  measure: Intra operative heart rate
  time frame: within 24 hours postoperative
  description: beats per minutes
  measure: Visual Analogue Scale
  time frame: 1, 2, 4, 6, 8, 12 and 24 hours postoperative
  description: VAS score at rest and during movement and cough The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
  measure: Nausea and vomiting
  time frame: intraoperative and postoperative 24 hours
  description: Nausea and vomiting
  measure: Onset of motor block using Bromage scale
  time frame: Post spinal anesthesia up to 30 minutes
  description: defined as the time from giving spinal anesthesia until a modified Bromage score of IV will be reached),Duration of motor block (defined as the time from spinal anesthesia until Modified Bromage score of I).
  measure: Onset of sensory block
  time frame: Post spinal anesthesia up to 30 minutes
  description: defined as the time needed to lose cold sensation when using the ice-cold test at the T6 dermatome level) and time to 2-segment regression of spinal anesthesia.
  measure: Neonatal Apgar score
  time frame: at 1 and 5 minutes post delivery
  description: This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2.
  measure: Complications of spinal anaesthesia and TAP block
  time frame: 12 hours post operative period.
  description: Complications of spinal anaesthesia and TAP block
  measure: Incidence of hypotension
  time frame: post spinal anesthesia up to 1 hour
  description: systolic blood pressure < 90 or <70% of baseline
  measure: Incidence of bradycardia
  time frame: post spinal anesthesia up to 1 hour
  description: heart rate less than 60 beats per minute
  arm group label: Group(A)
  arm group type: Active Comparator
  description: Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg and TAP block will be performed with 30 ml 0.25% bupivacaine in each side.
  arm group label: Group (B)
  arm group type: Active Comparator
  description: Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine10-12 mg and TAP block will be performed with 50 mcg Dexmedetomidine added to 30ml 0.25% bupivacaine in each side.
  arm group label: Group (C)
  arm group type: Active Comparator
  description: Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg added to 5 mcg dexmedetomidine. TAP block will be performed with 30ml 0.25% bupivacaine in each side.
  intervention type: Drug
  intervention name: Dexmedetomidine
  description: All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications. The required laboratory work will be: complete blood count (CBC); prothrombin time and concentration (PT&PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT); liver function tests and kidney function tests.
  Before arrival to the operation room (OR), women will be premedicated by metoclopramide 10mg and ranitidine 50 mg intravenous. Intra operatively, hemodynamics will be recorded baseline before spinal anaesthesia , after its performance, every 3 minutes until delivery and then every 10 minutes till the end of the CS. Any change within 20% of baseline will be accepted and any changes more than 20% will be managed according to guidelines. All groups will be anaesthetized to preform CS with conventional spinal anaesthesia. The TAP block group will receive a landmark orientated Ultrasound guided bilateral TAP block.
  arm group label: Group (B)
  arm group label: Group (C)
  arm group label: Group(A)
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Mohamed Ahmed Mohamed Youssef Ollaek
  investigator title: Assistant Professor
  mesh term: Dexmedetomidine
  sharing ipd: No