Post Operative Cognitive Dysfunction After Oncologic Surgery

StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary endpoint added 6 → 7 primary endpoints
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Record History

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  1. Primary endpoint(s) modified
    • Study title revised
    • Eligibility criteria expanded, about 4 words
    • Study description expanded, about 5 words
  2. Primary completion date: Nov 30, 2025 to Nov 30, 2027
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    v13
  3. Re-verified, no change to tracked fieldsv12
  4. Primary endpoints revised (6)v11
  5. Primary endpoints revised (6)
    • Study description expanded, about 11 words
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Jul 31, 2024 to Nov 30, 2025
    • Primary endpoints: 5 to 6
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v9
  2. Primary completion date: Jul 31, 2023 to Jul 31, 2024
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    v8
  3. Primary completion date: Jul 31, 2021 to Jul 31, 2023
    • Study completion date: Jul 31, 2021 to Dec 31, 2023
    v7
  4. Primary and study completion dates: Jul 31, 2020 to Jul 31, 2021v6
  5. Primary completion date: Dec 31, 2019 to Jul 31, 2020
    • Study completion date: Jan 31, 2020 to Jul 31, 2020
    v5
  6. Primary endpoints: 4 to 5v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints: 3 to 4
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2019 to Jul 3, 2019
    v3
  8. Primary completion date: Mar 5, 2019 to Dec 31, 2019
    • Start date: Jan 7, 2019 to Jul 1, 2019
    • Study completion date: Apr 1, 2019 to Jan 31, 2020
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, and Postoperative Delirium, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values as well as to Pupillometry values (in particular Pupil Diameter, Pupil Latency, and Maximum Contraction Velocity).
Trial Details
NCT Number NCT03774420
Lead Sponsor University of Padova
Conditions
(from sponsor)		 Emergence Delirium, Post-Operative Cognitive Dysfunction
Related terms Emergence Delirium
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov