<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/NCT03764267</url>
  </required_header>
  <id_info>
    <org_study_id>Ainshamsuni-MAC-wbakhet</org_study_id>
    <nct_id>NCT03764267</nct_id>
  </id_info>
  <brief_title>MAC vs TIVA Ambulatory Breast Augmentation</brief_title>
  <official_title>Monitored Anesthesia Care Using Remifentanil and Ketofol Results in a Superior Quality of Recovery Compared With Total Intravenous Anesthesia in Ambulatory Breast Augmentation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      hypothesis: the combination of LA with remifentanil and ketofol [monitored anesthesia care&#xD;
      (MAC)] for ambulatory breast augmentation may result in results in better QoR on day of&#xD;
      surgery as compared with total i.v. anesthesia (TIVA) . The purpose of this study was to&#xD;
      compare the QoR after MAC using remifentanil and ketofol with TIVA during ambulatory breast&#xD;
      augmentation .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast augmentation surgery is commonly performed on an ambulatory basis under under general&#xD;
      anesthesia (GA) with propofol and remifentanil or local anesthesia (LA). Although surgeons&#xD;
      perform this operation comfortably under GA, Patients have anxiety and fear of complications&#xD;
      due to GA. In addition, they expect a good postoperative quality of recovery (QOR) including&#xD;
      ability to resume common activities (work and daily activities) without suffering from&#xD;
      moderate to severe pain.&#xD;
&#xD;
      The LA is advantageous over GA in that airway instrumentation is not necessary, favorable&#xD;
      recovery profile, decrease postoperative pain and vomiting, increase patient satisfaction and&#xD;
      decrease the cost . However, patient anxiety or pain often leading to conversion of LA to GA,&#xD;
      which suggests the concomitant use of i.v. sedatives and analgesics as a supplement to LA.&#xD;
&#xD;
      The combination of remifentanil and ketofol (propofol, ketamine) for sedation during regional&#xD;
      anesthesia and LA has been shown to be a safe, effective technique, capable of maintains&#xD;
      adequate analgesia with conscious sedation, haemodynamic stability, and achieves lower&#xD;
      incidence of postoperative nausea and vomiting with shorter recovery times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <phase>Phase 3</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of recovery</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>Quality of recovery-40 (QoR-40) questionnaire, which includes five general quality of life dimensions: physical independence (5 items), pain (7 items), .emotional state (9 items), psychological support (7 items), and physical independence (5 items). Each item was graded with a 5-point score: none of the time, some of the time,usually, most of the time and all of the time. The total score on the QoR- 40 questionnaire ranges from 40 to 200 representing, respectively, extremely poor to excellent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recovery room readiness times</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>home readiness times</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>vomiting</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Breast Diseases</condition>
  <arm_group>
    <arm_group_label>remifentanil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MAC group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>general anesthetic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TIVA group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>Five minutes before infiltration of the local anesthestic by the surgeon, patients received an initial maintenance infusion of remifentanil 0.1 µg/kg/min and ketofol mixture 0.3 ml/kg (propofol 25 µg /kg/min and ketamine 10 µg/kg/min). ketofol mixture was prepared in a ratio of 1:2.5 (100 mg ketamine 2 mL (100 mg), propofol 1% 25 mL (250 mg), and glucose 5% 23 ml, total volume of 50 ml, each ml contain 2 mg ketamine + 5 mg propofol).&#xD;
Throughout the surgery, titration of the infusion rate of the remifentanil and ketofol were indicated by vital signs and expression of pain</description>
    <arm_group_label>remifentanil</arm_group_label>
    <other_name>lidocaine, ropivaicaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>general anesthetic</intervention_name>
    <description>general anesthetic was induced with a bolus dose of remifentanil (1 ug/kg over 30 second) and propofol (2 mg/kg) followed by insertion of a laryngeal mask airway (LMA). After the induction of anaesthesia and securing the airway, patient' lungs were ventilated with volume controlled ventilation, 50% oxygen/air mixtures in a circle system. .Anesthesia was maintained with remifentanil (0.5 ug/ kg/ min) and propofol (5 mg/kg/h). Remifentanil and propofol titrated to keep heart rate and the blood pressure within 20% of the baseline values and maintain BIS between 40 and 60, respectively. Patient movements were treated with additional i.v. bolus doses of remifentanil 0.5 ug/kg</description>
    <arm_group_label>general anesthetic</arm_group_label>
    <other_name>total intravenous anesthesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I, II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA III&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Wahba bakhet</investigator_full_name>
    <investigator_title>Lectrure of anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, General</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03764267
org study id: Ainshamsuni-MAC-wbakhet
nct id: NCT03764267
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
hypothesis: the combination of LA with remifentanil and ketofol [monitored anesthesia care
      (MAC)] for ambulatory breast augmentation may result in results in better QoR on day of
      surgery as compared with total i.v. anesthesia (TIVA) . The purpose of this study was to
      compare the QoR after MAC using remifentanil and ketofol with TIVA during ambulatory breast
      augmentation .
Breast augmentation surgery is commonly performed on an ambulatory basis under under general
      anesthesia (GA) with propofol and remifentanil or local anesthesia (LA). Although surgeons
      perform this operation comfortably under GA, Patients have anxiety and fear of complications
      due to GA. In addition, they expect a good postoperative quality of recovery (QOR) including
      ability to resume common activities (work and daily activities) without suffering from
      moderate to severe pain.

      The LA is advantageous over GA in that airway instrumentation is not necessary, favorable
      recovery profile, decrease postoperative pain and vomiting, increase patient satisfaction and
      decrease the cost . However, patient anxiety or pain often leading to conversion of LA to GA,
      which suggests the concomitant use of i.v. sedatives and analgesics as a supplement to LA.

      The combination of remifentanil and ketofol (propofol, ketamine) for sedation during regional
      anesthesia and LA has been shown to be a safe, effective technique, capable of maintains
      adequate analgesia with conscious sedation, haemodynamic stability, and achieves lower
      incidence of postoperative nausea and vomiting with shorter recovery times.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Quality of recovery
time frame: 24 hours postoperative
description: Quality of recovery-40 (QoR-40) questionnaire, which includes five general quality of life dimensions: physical independence (5 items), pain (7 items), .emotional state (9 items), psychological support (7 items), and physical independence (5 items). Each item was graded with a 5-point score: none of the time, some of the time,usually, most of the time and all of the time. The total score on the QoR- 40 questionnaire ranges from 40 to 200 representing, respectively, extremely poor to excellent
measure: Recovery room readiness times
time frame: 24 hours postoperative
description: minutes
measure: home readiness times
time frame: 24 hours postoperative
description: minutes
measure: adverse events
time frame: 24 hours postoperative
description: vomiting
arm group label: remifentanil
arm group type: Active Comparator
description: MAC group
arm group label: general anesthetic
arm group type: Active Comparator
description: TIVA group
intervention type: Drug
intervention name: Remifentanil
description: Five minutes before infiltration of the local anesthestic by the surgeon, patients received an initial maintenance infusion of remifentanil 0.1 µg/kg/min and ketofol mixture 0.3 ml/kg (propofol 25 µg /kg/min and ketamine 10 µg/kg/min). ketofol mixture was prepared in a ratio of 1:2.5 (100 mg ketamine 2 mL (100 mg), propofol 1% 25 mL (250 mg), and glucose 5% 23 ml, total volume of 50 ml, each ml contain 2 mg ketamine + 5 mg propofol).
Throughout the surgery, titration of the infusion rate of the remifentanil and ketofol were indicated by vital signs and expression of pain
arm group label: remifentanil
other name: lidocaine, ropivaicaine
intervention type: Drug
intervention name: general anesthetic
description: general anesthetic was induced with a bolus dose of remifentanil (1 ug/kg over 30 second) and propofol (2 mg/kg) followed by insertion of a laryngeal mask airway (LMA). After the induction of anaesthesia and securing the airway, patient' lungs were ventilated with volume controlled ventilation, 50% oxygen/air mixtures in a circle system. .Anesthesia was maintained with remifentanil (0.5 ug/ kg/ min) and propofol (5 mg/kg/h). Remifentanil and propofol titrated to keep heart rate and the blood pressure within 20% of the baseline values and maintain BIS between 40 and 60, respectively. Patient movements were treated with additional i.v. bolus doses of remifentanil 0.5 ug/kg
arm group label: general anesthetic
other name: total intravenous anesthesia
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Wahba bakhet
investigator title: Lectrure of anesthesia
mesh term: Breast Diseases
mesh term: Lidocaine
mesh term: Remifentanil
mesh term: Anesthetics
mesh term: Anesthetics, General
sharing ipd: Undecided