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

NCT04765488 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-08

No results posted yet for this study

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.

Conditions

  • Agitation, Emergence
  • Postoperative Delirium
  • Postoperative Cognitive Dysfunction

Interventions

PROCEDURE

WashIn /WashOut

According "Wash In / WashOut" procedure in study group we stop the supply of sevoflurane to the first signs of awakening and record the level of sevoflurane , then we resume the supply of sevoflurane to the end-tidal concentration of 1 MAC maintain the anesthesia for 5 min and stop the supply of sevoflurane to the first signs of awakening again, then we resume the supply of sevoflurane to the end-tidal concentration of 1 MAC maintain the anesthesia for 5 min and finally ( the third time) stop supplying sevoflurane and extubate patient after recovery of muscle tone, spontaneous breathing and consciousness.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Valery Likhvantsev · I.M. Sechenov First Moscow State Medical University (Sechenov University); Head of Research V. Negovsky Reanimatology Research Institute

  • Giovanni Landoni · San Raffaele Scientific Institute

  • Pavel Bagdasarov · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2025-02-25
Completion
2026-02-25

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04765488 on ClinicalTrials.gov