<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/NCT02988050</url>
  </required_header>
  <id_info>
    <org_study_id>MenoufiaU2016</org_study_id>
    <nct_id>NCT02988050</nct_id>
  </id_info>
  <brief_title>Conscious Sedation for Epilepsy Surgery</brief_title>
  <official_title>Propofol-dexmedetomidine Versus Propofol-remifentanil Conscious Sedation for Awake Craniotomy During Epilepsy Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menoufia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Menoufia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sixty patients were randomly allocated into two groups, group PD and group PR, thirty&#xD;
      patients in each group. Patients in PD group received propofol and dexmedetomidine&#xD;
      intravenous infusion and patients in PR group received propofol and remifentanil intravenous&#xD;
      infusion. Sedation score and patients' satisfaction, surgeon satisfaction, heart rate, mean&#xD;
      arterial blood pressure, oxygen saturation, and side effects such as respiratory depression,&#xD;
      nausea, vomiting, airway obstruction, and oxygen desaturation were recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval from the ethics committee of Menoufia University Hospitals and informed&#xD;
      written consent, the present study was conducted on sixty patients of both sexes. Patients'&#xD;
      age was between 18-50 years, American society of anesthesiologists (ASA) I and II and&#xD;
      scheduled for awake craniotomy for treatment of epilepsy. Exclusion criteria included&#xD;
      patients with history of allergy to any of the drugs used for the study, patients with&#xD;
      alcohol or substance abuse, pregnant females, patients with mental instability, morbid obese&#xD;
      patients, and patients with liver, kidney, or cardiac comorbidities.&#xD;
&#xD;
      Patients were randomly allocated using computerized software into two groups, thirty patients&#xD;
      in each group to receive intra-operative either propofol-dexmedetomidine (PD group) or&#xD;
      propofol-remifentanil (PR group) intravenous infusion. All patients received their routine&#xD;
      treatment for epilepsy at their scheduled time before surgery. All patients were fully&#xD;
      monitored intra-operatively for heart rate, non-invasive blood pressure, oxygen saturation,&#xD;
      respiratory rate, and bi-spectral index (BIS). Oxygen was supplied to all patients via nasal&#xD;
      cannula peri-operatively.&#xD;
&#xD;
      Anaesthesia was achieved by regional scalp block and IV sedation. Regional blockade of the&#xD;
      scalp was performed using bupivacaine 0.5% and 2% lidocaine with epinephrine 1/200.000. The&#xD;
      branches of the cranial nerves blocked were supratrochlear, supraorbital, auriculotemporal,&#xD;
      greater and lesser occipital, great auricular, zygomatic, and infraorbital nerves.&#xD;
      Supplemental local anesthetic solution was used to infiltrate along the incision lines prior&#xD;
      to skin incision. During craniotomy, a mixture of 0.25% bupivacaine and lidocaine1% without&#xD;
      epinephrine was used to anesthetize the dura mater. The maximum dose of lidocaine used did&#xD;
      not exceed 4.5 mg kg -1 and for bupivacaine 3 mg kg -1.&#xD;
&#xD;
      All patients received propofol 1% with a starting intravenous infusion dose of 250 μg kg-1&#xD;
      min-1 for 15 min and then basal infusion dose at 50 μg kg-1min-1. Sedation was achieved for&#xD;
      group PD by a combination of propofol and dexmedetomidine with a starting infusion dose of&#xD;
      1ug kg-1 hr -1 for 15 min, and then titrated down to 0.2μ g kg-1 hr-1.&#xD;
&#xD;
      In PR group, IV sedation was achieved by a combination of propofol and remifentanil at an&#xD;
      initial bolus dose of 0.5 μg.kg-1 over 60 seconds and then a basal infusion of 0.1μg kg-1&#xD;
      min1. Insufficient sedation in both groups was treated with boluses of 250 μg kg-1 propofol.&#xD;
      The total amount of propofol used in both groups was recorded.&#xD;
&#xD;
      Sedation was assessed using Ramsay sedation score.6 Patient scored (1) if was anxious,&#xD;
      agitated, or restless. Patient scored (2) if was cooperative, oriented and tranquil. Score 3&#xD;
      was for patients responded to command only. Score (4) for patients exhibited brisk respond to&#xD;
      light glabellar tap or loud auditory stimulus. Score (5) for patients exhibited a sluggish&#xD;
      response to light glabellar tap or loud auditory stimulus. Score (6) was for patients&#xD;
      exhibited no response. Score (1) means inadequate sedation, score (2 to 4) means acceptable&#xD;
      sedation, and score (5) or (6) means excessive sedation. Bi-spectral index (BIS) was&#xD;
      connected to all patients and recorded every half an hour intra-operatively until the end&#xD;
      surgery.&#xD;
&#xD;
      For intraoperative neurophysiologic monitoring propofol infusion was stopped for 15 minutes&#xD;
      to avoid interference.&#xD;
&#xD;
      Side effects such as respiratory depression (respiratory rate less than 8/min), nausea,&#xD;
      vomiting, airway obstruction, oxygen desaturation (oxygen saturation less than 90 %), and&#xD;
      hypotension or hypertension (20% decrease or increase from the base line) were recorded. In&#xD;
      case of apnea, respiratory depression, oxygen desaturation, and airway obstruction or&#xD;
      hypotension all infusions were stopped until normalization and then the infusion resumed at&#xD;
      half the basal rate. Vomiting was treated with 4mg intravenous ondansetron and the total&#xD;
      ondansetron consumption was recorded for both groups.&#xD;
&#xD;
      If intraoperative convulsions occurred at any time IV thiopental sodium was given at a dose&#xD;
      1-2 mg kg-1. General anaesthesia was given if indicated and the patient was removed from the&#xD;
      study. The excluded patients were replaced according to the schedule of randomization to keep&#xD;
      the number of the two groups. Indications for general anesthesia were failure of the regional&#xD;
      block, marked patient irritability, severe airway obstruction required intubation,&#xD;
      uncontrolled convulsions, and haemodynamic instability.&#xD;
&#xD;
      Patient's satisfaction was recorded using a score ranging from 0 not satisfied and 10 totally&#xD;
      satisfied. Surgeon satisfaction regarding the operative conditions and the anesthetic&#xD;
      technique was recorded as 0 very bad operative conditions, 1 moderate, and 2 good.&#xD;
&#xD;
      Statistical analysis Sample size calculation was calculated using graphed instant statistics&#xD;
      version 3. Based on previous research, dexmedetomidine was expected to produce a decrease in&#xD;
      the heart rate by about 10 beats /minute with a standard deviation of 10 and by choosing 5%&#xD;
      level of significance and power of 90% the calculated sample size was 22 so that, the sample&#xD;
      size used in the study was 30 patients to ensure reliable results.&#xD;
&#xD;
      Data were analyzed using SPSS 19 program. Student t-test was used for comparing data between&#xD;
      the two groups. Chi square test was used to compare the incidence of side effects. P value of&#xD;
      less than 0.05 was considered to be statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients Satisfaction</measure>
    <time_frame>1 hour after the operation</time_frame>
    <description>Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Propofol-dexmedetomidine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol-remifentanil</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>Remifentanil used for conscious sedation.</description>
    <arm_group_label>Propofol-remifentanil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine used for conscious sedation.</description>
    <arm_group_label>Propofol-dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Used for conscious sedation.</description>
    <arm_group_label>Propofol-dexmedetomidine</arm_group_label>
    <arm_group_label>Propofol-remifentanil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Local anaesthetics</description>
    <arm_group_label>Propofol-dexmedetomidine</arm_group_label>
    <arm_group_label>Propofol-remifentanil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Local anaesthetic</description>
    <arm_group_label>Propofol-dexmedetomidine</arm_group_label>
    <arm_group_label>Propofol-remifentanil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epinephrine</intervention_name>
    <description>With local anaesthetic for skin infiltration.</description>
    <arm_group_label>Propofol-dexmedetomidine</arm_group_label>
    <arm_group_label>Propofol-remifentanil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients require conscious sedation for epilepsy surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusal, allergy to drugs used, and uncooperative patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>August 10, 2020</results_first_submitted>
  <results_first_submitted_qc>September 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 9, 2020</results_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Menoufia University</investigator_affiliation>
    <investigator_full_name>Dr Ezzeldin Ibrahim</investigator_full_name>
    <investigator_title>Assistant Professor in anaesthesia, intensive care, and pain medicine</investigator_title>
  </responsible_party>
  <keyword>Epilepsy Surgery</keyword>
  <keyword>Conscious sedation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Patients were excluded if they refused to be included in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Propofol-dexmedetomidine</title>
          <description>Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)&#xD;
Dexmedetomidine: Dexmedetomidine used for conscious sedation.&#xD;
Propofol: Used for conscious sedation.&#xD;
Bupivacaine: Local anaesthetics&#xD;
Lidocaine: Local anaesthetic&#xD;
Epinephrine: With local anaesthetic for skin infiltration.</description>
        </group>
        <group group_id="P2">
          <title>Propofol-remifentanil</title>
          <description>Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)&#xD;
Remifentanil: Remifentanil used for conscious sedation.&#xD;
Propofol: Used for conscious sedation.&#xD;
Bupivacaine: Local anaesthetics&#xD;
Lidocaine: Local anaesthetic&#xD;
Epinephrine: With local anaesthetic for skin infiltration.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Propofol-dexmedetomidine</title>
          <description>Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)&#xD;
Dexmedetomidine: Dexmedetomidine used for conscious sedation.&#xD;
Propofol: Used for conscious sedation.&#xD;
Bupivacaine: Local anaesthetics&#xD;
Lidocaine: Local anaesthetic&#xD;
Epinephrine: With local anaesthetic for skin infiltration.</description>
        </group>
        <group group_id="B2">
          <title>Propofol-remifentanil</title>
          <description>Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)&#xD;
Remifentanil: Remifentanil used for conscious sedation.&#xD;
Propofol: Used for conscious sedation.&#xD;
Bupivacaine: Local anaesthetics&#xD;
Lidocaine: Local anaesthetic&#xD;
Epinephrine: With local anaesthetic for skin infiltration.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.5" spread="10.5"/>
                    <measurement group_id="B2" value="33.4" spread="10.5"/>
                    <measurement group_id="B3" value="33" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Egypt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patients Satisfaction</title>
        <description>Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.</description>
        <time_frame>1 hour after the operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conscious sedation1</title>
            <description>Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)&#xD;
Dexmedetomidine: Dexmedetomidine used for conscious sedation.&#xD;
Propofol: Used for conscious sedation.&#xD;
Bupivacaine: Local anaesthetics&#xD;
Lidocaine: Local anaesthetic&#xD;
Epinephrine: With local anaesthetic for skin infiltration.</description>
          </group>
          <group group_id="O2">
            <title>Conscious sedation2</title>
            <description>propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)&#xD;
Remifentanil: Remifentanil used for conscious sedation.&#xD;
Propofol: Used for conscious sedation.&#xD;
Bupivacaine: Local anaesthetics&#xD;
Lidocaine: Local anaesthetic&#xD;
Epinephrine: With local anaesthetic for skin infiltration.</description>
          </group>
        </group_list>
        <measure>
          <title>Patients Satisfaction</title>
          <description>Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.33" spread="1.36"/>
                    <measurement group_id="O2" value="6.45" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the operation, on average 3 hours.</time_frame>
      <desc>Apnea and airway obstruction.</desc>
      <group_list>
        <group group_id="E1">
          <title>Propofol-dexmedetomidine</title>
          <description>Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)&#xD;
Dexmedetomidine: Dexmedetomidine used for conscious sedation.&#xD;
Propofol: Used for conscious sedation.&#xD;
Bupivacaine: Local anaesthetics&#xD;
Lidocaine: Local anaesthetic&#xD;
Epinephrine: With local anaesthetic for skin infiltration.</description>
        </group>
        <group group_id="E2">
          <title>Propofol-remifentanil</title>
          <description>Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)&#xD;
Remifentanil: Remifentanil used for conscious sedation.&#xD;
Propofol: Used for conscious sedation.&#xD;
Bupivacaine: Local anaesthetics&#xD;
Lidocaine: Local anaesthetic&#xD;
Epinephrine: With local anaesthetic for skin infiltration.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Professor Ezzeldin Ibrahim, Professor of Anaesthesia</name_or_title>
      <organization>Menoufia University</organization>
      <phone>00201006303178</phone>
      <email>ezzeldin7@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02988050
org study id: MenoufiaU2016
nct id: NCT02988050
lead sponsor: 
has dmc: No
Sixty patients were randomly allocated into two groups, group PD and group PR, thirty
      patients in each group. Patients in PD group received propofol and dexmedetomidine
      intravenous infusion and patients in PR group received propofol and remifentanil intravenous
      infusion. Sedation score and patients' satisfaction, surgeon satisfaction, heart rate, mean
      arterial blood pressure, oxygen saturation, and side effects such as respiratory depression,
      nausea, vomiting, airway obstruction, and oxygen desaturation were recorded.
After approval from the ethics committee of Menoufia University Hospitals and informed
      written consent, the present study was conducted on sixty patients of both sexes. Patients'
      age was between 18-50 years, American society of anesthesiologists (ASA) I and II and
      scheduled for awake craniotomy for treatment of epilepsy. Exclusion criteria included
      patients with history of allergy to any of the drugs used for the study, patients with
      alcohol or substance abuse, pregnant females, patients with mental instability, morbid obese
      patients, and patients with liver, kidney, or cardiac comorbidities.

      Patients were randomly allocated using computerized software into two groups, thirty patients
      in each group to receive intra-operative either propofol-dexmedetomidine (PD group) or
      propofol-remifentanil (PR group) intravenous infusion. All patients received their routine
      treatment for epilepsy at their scheduled time before surgery. All patients were fully
      monitored intra-operatively for heart rate, non-invasive blood pressure, oxygen saturation,
      respiratory rate, and bi-spectral index (BIS). Oxygen was supplied to all patients via nasal
      cannula peri-operatively.

      Anaesthesia was achieved by regional scalp block and IV sedation. Regional blockade of the
      scalp was performed using bupivacaine 0.5% and 2% lidocaine with epinephrine 1/200.000. The
      branches of the cranial nerves blocked were supratrochlear, supraorbital, auriculotemporal,
      greater and lesser occipital, great auricular, zygomatic, and infraorbital nerves.
      Supplemental local anesthetic solution was used to infiltrate along the incision lines prior
      to skin incision. During craniotomy, a mixture of 0.25% bupivacaine and lidocaine1% without
      epinephrine was used to anesthetize the dura mater. The maximum dose of lidocaine used did
      not exceed 4.5 mg kg -1 and for bupivacaine 3 mg kg -1.

      All patients received propofol 1% with a starting intravenous infusion dose of 250 μg kg-1
      min-1 for 15 min and then basal infusion dose at 50 μg kg-1min-1. Sedation was achieved for
      group PD by a combination of propofol and dexmedetomidine with a starting infusion dose of
      1ug kg-1 hr -1 for 15 min, and then titrated down to 0.2μ g kg-1 hr-1.

      In PR group, IV sedation was achieved by a combination of propofol and remifentanil at an
      initial bolus dose of 0.5 μg.kg-1 over 60 seconds and then a basal infusion of 0.1μg kg-1
      min1. Insufficient sedation in both groups was treated with boluses of 250 μg kg-1 propofol.
      The total amount of propofol used in both groups was recorded.

      Sedation was assessed using Ramsay sedation score.6 Patient scored (1) if was anxious,
      agitated, or restless. Patient scored (2) if was cooperative, oriented and tranquil. Score 3
      was for patients responded to command only. Score (4) for patients exhibited brisk respond to
      light glabellar tap or loud auditory stimulus. Score (5) for patients exhibited a sluggish
      response to light glabellar tap or loud auditory stimulus. Score (6) was for patients
      exhibited no response. Score (1) means inadequate sedation, score (2 to 4) means acceptable
      sedation, and score (5) or (6) means excessive sedation. Bi-spectral index (BIS) was
      connected to all patients and recorded every half an hour intra-operatively until the end
      surgery.

      For intraoperative neurophysiologic monitoring propofol infusion was stopped for 15 minutes
      to avoid interference.

      Side effects such as respiratory depression (respiratory rate less than 8/min), nausea,
      vomiting, airway obstruction, oxygen desaturation (oxygen saturation less than 90 %), and
      hypotension or hypertension (20% decrease or increase from the base line) were recorded. In
      case of apnea, respiratory depression, oxygen desaturation, and airway obstruction or
      hypotension all infusions were stopped until normalization and then the infusion resumed at
      half the basal rate. Vomiting was treated with 4mg intravenous ondansetron and the total
      ondansetron consumption was recorded for both groups.

      If intraoperative convulsions occurred at any time IV thiopental sodium was given at a dose
      1-2 mg kg-1. General anaesthesia was given if indicated and the patient was removed from the
      study. The excluded patients were replaced according to the schedule of randomization to keep
      the number of the two groups. Indications for general anesthesia were failure of the regional
      block, marked patient irritability, severe airway obstruction required intubation,
      uncontrolled convulsions, and haemodynamic instability.

      Patient's satisfaction was recorded using a score ranging from 0 not satisfied and 10 totally
      satisfied. Surgeon satisfaction regarding the operative conditions and the anesthetic
      technique was recorded as 0 very bad operative conditions, 1 moderate, and 2 good.

      Statistical analysis Sample size calculation was calculated using graphed instant statistics
      version 3. Based on previous research, dexmedetomidine was expected to produce a decrease in
      the heart rate by about 10 beats /minute with a standard deviation of 10 and by choosing 5%
      level of significance and power of 90% the calculated sample size was 22 so that, the sample
      size used in the study was 30 patients to ensure reliable results.

      Data were analyzed using SPSS 19 program. Student t-test was used for comparing data between
      the two groups. Chi square test was used to compare the incidence of side effects. P value of
      less than 0.05 was considered to be statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Patients Satisfaction
time frame: 1 hour after the operation
description: Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.
arm group label: Propofol-dexmedetomidine
arm group type: Other
description: Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)
arm group label: Propofol-remifentanil
arm group type: Other
description: Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)
intervention type: Drug
intervention name: Remifentanil
description: Remifentanil used for conscious sedation.
arm group label: Propofol-remifentanil
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine used for conscious sedation.
arm group label: Propofol-dexmedetomidine
intervention type: Drug
intervention name: Propofol
description: Used for conscious sedation.
arm group label: Propofol-dexmedetomidine
arm group label: Propofol-remifentanil
intervention type: Drug
intervention name: Bupivacaine
description: Local anaesthetics
arm group label: Propofol-dexmedetomidine
arm group label: Propofol-remifentanil
intervention type: Drug
intervention name: Lidocaine
description: Local anaesthetic
arm group label: Propofol-dexmedetomidine
arm group label: Propofol-remifentanil
intervention type: Drug
intervention name: Epinephrine
description: With local anaesthetic for skin infiltration.
arm group label: Propofol-dexmedetomidine
arm group label: Propofol-remifentanil
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Menoufia University
investigator full name: Dr Ezzeldin Ibrahim
investigator title: Assistant Professor in anaesthesia, intensive care, and pain medicine
mesh term: Epilepsy
mesh term: Lidocaine
mesh term: Epinephrine
mesh term: Dexmedetomidine
mesh term: Remifentanil
mesh term: Bupivacaine
mesh term: Propofol
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 