<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/NCT04433416</url>
  </required_header>
  <id_info>
    <org_study_id>SH9H-2020-T21-3</org_study_id>
    <nct_id>NCT04433416</nct_id>
  </id_info>
  <brief_title>Hypertension and Controlled Hypotension in the Elderly</brief_title>
  <official_title>Effect of Preoperative Hypertension and Controlled Hypotension on Postoperative Delirium in the Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhang Lei</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparision of Exposed Factors of Preoperative Hypertension and Intraoperative Controlled&#xD;
      Hypotension on Postoperative Delirium in the Elderly under Radical Resection of Head, Neck&#xD;
      and Maxillofacial Tumor&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative delirium has a higher incidence in elderly patients after general&#xD;
      anesthesia，and It is closely related to the type of surgery, the length of surgery, and the&#xD;
      patient's physique.Because head and neck maxillofacial radical surgery requires free flap&#xD;
      transplantation and longer duration,and hemorrhage is more when the primary focus is&#xD;
      removed，Intraoperative blood pressure reduction is needed to reduce bleeding，therefore,&#xD;
      hypoperfusion of craniocerebral blood flow will occur.Low cerebral perfusion is closely&#xD;
      related to the occurrence of postoperative delirium.Patients undergoing this type of surgery&#xD;
      have more preoperative complications，hypertension is particularly common.Therefore, this&#xD;
      study mainly studied the correlation between the preoperative blood pressure level and the&#xD;
      controlled hypotension level in patients with radical head and neck and maxillofacial tumors&#xD;
      and the incidence of postoperative delirium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2020</start_date>
  <completion_date type="Actual">December 7, 2020</completion_date>
  <primary_completion_date type="Actual">December 7, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Days</target_duration>
  <primary_outcome>
    <measure>Degree of delirium</measure>
    <time_frame>up to three days after surgery</time_frame>
    <description>From the first to the third day after surgery, the patient will be evaluated for delirium using the CAM scale.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">98</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>hypertension</arm_group_label>
    <description>After admission, two or more of the three blood pressure measurements under the same period of calm state that met hypertension, and the patient reported that he had a history of hypertension and that the blood pressure reached the standard of hypertension in the previous non-medication state was included in the hypertension group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-hypertension</arm_group_label>
    <description>Patients who denied the history of hypertension and were not taking antihypertensive drugs after admission and had normal blood pressure measurements were included in the non-hypertensive group</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>hypertension</intervention_name>
    <description>If the patient has two or more blood pressure values ≥140/90mmHg in a calm state, he is included in this group</description>
    <arm_group_label>hypertension</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The subject was a patient undergoing radical surgery for general anesthesia for mandibular&#xD;
        and facial malignant tumors. The patients who had just been admitted to the hospital were&#xD;
        preoperatively visited 2-3 days before the operation. According to whether the patient had&#xD;
        a history of hypertension and the blood pressure value in the calm state after three&#xD;
        admissions, Patients were divided into hypertensive group and non-hypertensive group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who underwent radical anesthesia for oral and maxillofacial malignant tumors&#xD;
             in our hospital&#xD;
&#xD;
          2. ASA grade is Ⅰ-Ⅱ&#xD;
&#xD;
          3. Patient is older than 60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient has mental and mental disorders (eg schizophrenia, Alzheimer's disease)&#xD;
&#xD;
          2. There was severe anemia before operation (Hb&lt;80g/L)&#xD;
&#xD;
          3. Patients had cerebral vascular complications such as cerebral infarction and lacunar&#xD;
             infarction before operation&#xD;
&#xD;
          4. Patients who do not cooperate with this trial&#xD;
&#xD;
          5. Long-term use of sedative drugs or analgesics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lei Zhang, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Study director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 9, 2021</last_update_submitted>
  <last_update_submitted_qc>January 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</investigator_affiliation>
    <investigator_full_name>Zhang Lei</investigator_full_name>
    <investigator_title>Deputy Chief Physician and Associate Researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04433416
org study id: SH9H-2020-T21-3
nct id: NCT04433416
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Comparision of Exposed Factors of Preoperative Hypertension and Intraoperative Controlled
      Hypotension on Postoperative Delirium in the Elderly under Radical Resection of Head, Neck
      and Maxillofacial Tumor
Postoperative delirium has a higher incidence in elderly patients after general
      anesthesia，and It is closely related to the type of surgery, the length of surgery, and the
      patient's physique.Because head and neck maxillofacial radical surgery requires free flap
      transplantation and longer duration,and hemorrhage is more when the primary focus is
      removed，Intraoperative blood pressure reduction is needed to reduce bleeding，therefore,
      hypoperfusion of craniocerebral blood flow will occur.Low cerebral perfusion is closely
      related to the occurrence of postoperative delirium.Patients undergoing this type of surgery
      have more preoperative complications，hypertension is particularly common.Therefore, this
      study mainly studied the correlation between the preoperative blood pressure level and the
      controlled hypotension level in patients with radical head and neck and maxillofacial tumors
      and the incidence of postoperative delirium.
observational model: Cohort
time perspective: Prospective
measure: Degree of delirium
time frame: up to three days after surgery
description: From the first to the third day after surgery, the patient will be evaluated for delirium using the CAM scale.
arm group label: hypertension
description: After admission, two or more of the three blood pressure measurements under the same period of calm state that met hypertension, and the patient reported that he had a history of hypertension and that the blood pressure reached the standard of hypertension in the previous non-medication state was included in the hypertension group
arm group label: non-hypertension
description: Patients who denied the history of hypertension and were not taking antihypertensive drugs after admission and had normal blood pressure measurements were included in the non-hypertensive group
intervention type: Diagnostic Test
intervention name: hypertension
description: If the patient has two or more blood pressure values ≥140/90mmHg in a calm state, he is included in this group
arm group label: hypertension
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Lei Zhang, Doctor
role: Study Director
affiliation: Study director
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
investigator full name: Zhang Lei
investigator title: Deputy Chief Physician and Associate Researcher
mesh term: Delirium
mesh term: Hypertension
mesh term: Hypotension
sharing ipd: No