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WashIn /WashOut Procedure To Prevent Agitation During Recovery After Inhalational Anesthesia With Sevoflurane

Study acronym: OPERA
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Sep 1, 2024 to Feb 25, 2025
    • Study completion date: Oct 1, 2024 to Feb 25, 2026
    • Site details revised at 3 of 3 sites
    v8
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Notable Primary completion date: Sep 1, 2023 to Sep 1, 2024
    • Study sites: 2 to 3
    • Study completion date: Oct 1, 2023 to Oct 1, 2024
    v6
  4. Notable Primary completion date: Sep 1, 2022 to Sep 1, 2023
    • Study sites: 1 to 2
    • Study completion date: Oct 1, 2022 to Oct 1, 2023
    • Eligibility criteria shortened, about 19 words
    v5
  5. Minor Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  2. Minor Start date: Feb 17, 2021 to Mar 10, 2021v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Inhalation anesthesia is the most frequently used technique and is performed in around 70% of surgeries worldwide. Sevoflurane is the most frequently used halogenated anesthetic and is used in 2/3 of the cases. The anesthetic strength of inhalation agents was established in the classic work of Eger and colleagues who determined the minimum alveolar concentration (MAC) of an inhaled anesthetic at atmospheric pressure, necessary to prevent a motor reaction in response to a pain stimulus in 50% of patients. Agitation is a frequent anesthesia complications and it not only lengthens the period of post anesthetic awakening and need for advance monitoring of the patient, but may be a predisposing factor in the development of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) which are independent predictors of increased mortality, prolonged treatment in the ICU and hospital, and prolonged social adaptation of the operated patients.(The ability of the patient to serve themselves independently.). There is a fairly popular point of view that there is no specific prophylaxis or treatment of postoperative agitation. However, a variant of anesthesia induction with sevoflurane was recently proposed, which reduced the frequency of agitation in children from 24.7% to 4.4%. The technique consisted in interrupting anesthesia at the moment of loss of consciousness, awakening the patient and subsequently performing re-induction. Since this technique might be time consuming in the busiest period of a surgical theatre and not safe if performed with the airways still unsecured it is advisable to shift the Wash In/Wash Out procedure to the stage of awakening at the end of surgery.
Trial Details
NCT Number NCT04765488
Lead Sponsor I.M. Sechenov First Moscow State Medical University
Conditions
(from sponsor)
Agitation, Emergence, Postoperative Delirium, Postoperative Cognitive Dysfunction
Related terms Emergence Delirium, Postoperative Cognitive Complications
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov