<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/NCT04473846</url>
  </required_header>
  <id_info>
    <org_study_id>67/2020/524</org_study_id>
    <nct_id>NCT04473846</nct_id>
  </id_info>
  <brief_title>Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures.</brief_title>
  <official_title>The Use of Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures: a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jordan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jordan</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>
      Conscious sedation provides adequate control of pain and anxiety for the majority of routine&#xD;
      endoscopic procedures as well as adequate amnesia. Sedation practices vary widely, with some&#xD;
      colonoscopists advocating sedation only for the most difficult cases of colonoscopy, while&#xD;
      others prefer using deep sedation or general anaesthesia for colonoscopy. However, many&#xD;
      physicians are still using moderate sedation for the majority of patients.&#xD;
&#xD;
      The use of propofol, a short acting anesthetic agent, for conscious sedation provides a&#xD;
      considerably more rapid onset of action and shorter recovery time, for which it is believed&#xD;
      to be a safe drug of choice for patients undergoing endoscopic procedures. Although propofol&#xD;
      cannot be used as a single agent for moderate sedation, it can be effectively titrated to&#xD;
      moderate sedation after administration of small doses of narcotics and sedatives.&#xD;
&#xD;
      The aim of this study is to compare between general anesthesia and deep sedation using&#xD;
      propofol-fentanyl-ketamine (PFK) preparation in terms of perioperative vital signs,&#xD;
      intraoperative awareness, post-operative pain scores, and the use of analgesia&#xD;
      postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transient decrease in oxygen saturation</measure>
    <time_frame>1 hour</time_frame>
    <description>the investigators will record any episodes of transient reduction of oxygen saturation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure stability</measure>
    <time_frame>1 hour</time_frame>
    <description>the investigators will record changes in blood pressure after induction of anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery time</measure>
    <time_frame>2 hours</time_frame>
    <description>the investigators will document recovery time in the post anesthesia care unit (PACU) until recovery of full consciousness.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>PF group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The first group will undergo general anesthesia using Fentanyl and Propofol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PFK group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The second group will receive a mixture that consists of Fentanyl, Propofol, and Ketamine. In addition, Lidocaine will be added to reduce the pain on injection caused by Propofol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PK general anesthesia</intervention_name>
    <description>Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).</description>
    <arm_group_label>PF group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PFK combination</intervention_name>
    <description>Each patient received an initial dose of 0.05 ml/kg from the solution, then after waiting for 60 seconds, another 0.05 ml/kg were given. Maintenance was given as boluses of 0.025 ml/kg every three to five minutes.</description>
    <arm_group_label>PFK group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who were admitted for endoscopic and colonoscopic procedures.&#xD;
&#xD;
          -  ASA (American Society of Anaesthesiologists physical status) score from 1 to 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal.&#xD;
&#xD;
          -  urgent and emergency cases, which were not elective procedures.&#xD;
&#xD;
          -  Surgeries that were expected to take a long duration (more than 1.5 hour).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Abdelkarim S AlOweidi</last_name>
    <phone>+962795712121</phone>
    <email>akaloweidi@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jordan University Hospital</name>
      <address>
        <city>Amman</city>
        <zip>13046</zip>
        <country>Jordan</country>
      </address>
    </facility>
    <contact>
      <last_name>Shawqi Saleh</last_name>
      <phone>+962795577922</phone>
      <email>sssaleh@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Noor Rammadan</last_name>
      <phone>+962796234137</phone>
      <email>nm_rammadan@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jordan</investigator_affiliation>
    <investigator_full_name>Abdelkarim Saleh AlOweidi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Anesthesia</keyword>
  <keyword>Endoscopy</keyword>
  <keyword>Colonoscopy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04473846
org study id: 67/2020/524
nct id: NCT04473846
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Conscious sedation provides adequate control of pain and anxiety for the majority of routine
      endoscopic procedures as well as adequate amnesia. Sedation practices vary widely, with some
      colonoscopists advocating sedation only for the most difficult cases of colonoscopy, while
      others prefer using deep sedation or general anaesthesia for colonoscopy. However, many
      physicians are still using moderate sedation for the majority of patients.

      The use of propofol, a short acting anesthetic agent, for conscious sedation provides a
      considerably more rapid onset of action and shorter recovery time, for which it is believed
      to be a safe drug of choice for patients undergoing endoscopic procedures. Although propofol
      cannot be used as a single agent for moderate sedation, it can be effectively titrated to
      moderate sedation after administration of small doses of narcotics and sedatives.

      The aim of this study is to compare between general anesthesia and deep sedation using
      propofol-fentanyl-ketamine (PFK) preparation in terms of perioperative vital signs,
      intraoperative awareness, post-operative pain scores, and the use of analgesia
      postoperatively.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Transient decrease in oxygen saturation
time frame: 1 hour
description: the investigators will record any episodes of transient reduction of oxygen saturation.
measure: Blood pressure stability
time frame: 1 hour
description: the investigators will record changes in blood pressure after induction of anesthesia
measure: Recovery time
time frame: 2 hours
description: the investigators will document recovery time in the post anesthesia care unit (PACU) until recovery of full consciousness.
arm group label: PF group
arm group type: Experimental
description: The first group will undergo general anesthesia using Fentanyl and Propofol.
arm group label: PFK group
arm group type: Experimental
description: The second group will receive a mixture that consists of Fentanyl, Propofol, and Ketamine. In addition, Lidocaine will be added to reduce the pain on injection caused by Propofol.
intervention type: Drug
intervention name: PK general anesthesia
description: Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).
arm group label: PF group
intervention type: Drug
intervention name: PFK combination
description: Each patient received an initial dose of 0.05 ml/kg from the solution, then after waiting for 60 seconds, another 0.05 ml/kg were given. Maintenance was given as boluses of 0.025 ml/kg every three to five minutes.
arm group label: PFK group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Abdelkarim S AlOweidi
phone: +962795712121
email: akaloweidi@hotmail.com
facility: 
contact: 
contact backup: 
country: Jordan
responsible party type: Principal Investigator
investigator affiliation: University of Jordan
investigator full name: Abdelkarim Saleh AlOweidi
investigator title: Principal Investigator
mesh term: Anesthetics