Clinical Trial

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

Study acronym: OPERA
Active, Not Recruiting
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Summary
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-02-19; most recent amendment 2025-07-02.
Status change: Recruiting → Active, Not Recruiting 2025-07-02
Status change: Not Yet Recruiting → Recruiting 2021-03-10
Trial Details
NCT Number NCT04765488
Lead Sponsor I.M. Sechenov First Moscow State Medical University
Conditions Agitation, Emergence, Postoperative Delirium, Postoperative Cognitive Dysfunction
Enrollment 200 participants
Start Date 2021-03-10
Primary Completion 2025-02-25 (estimated)
Study Completion 2026-02-25 (estimated)
Updated on ClinicalTrials.gov 2025-07-08