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

NCT04765488 | Active Not Recruiting DMC

• 1 other identifier: OPERA-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

emergence agitation; postoperative agitation; postoperative delirium; postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (2)

• The effect of "Wash In / WashOut" procedure on the incidence of postoperative agitation after anesthesia with sevoflurane.

  the patient scores +2 or more points on the RASS scale in one or more measurements, then he is diagnosed with agitation.

  during 30 minutes after awaking

• To estimate changes in the incidence of postoperative agitation on the RASS scale

  incidence of postoperative agitation in control group - incidence of postoperative agitation in study group

  during 30 minutes after awaking

Secondary Outcomes (6)

• To estimate changes in the incidence of postoperative delirium on the scales CAM-ICU, ICDSC

  3 days after surgery twice a day (a.m. and p.m.)

• To estimate changes in the incidence of postoperative cognitive impairment

  on the 7th day after surgery

• To estimate the incidence of postoperative nausea and vomiting, the need of using of antiemetics

  Since end of surgery prior to hospital discharge

• To estimate patient satisfaction with anesthesia on the ISAS scale

  At third postoperative day

• Length of stay in ICU

  ICU discharged

Study Arms (2)

Study group

EXPERIMENTAL

A group of patients in relation to whom the "Wash In / WashOut" procedure will be applied. In this 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.

Procedure: WashIn /WashOut

Control group

NO INTERVENTION

A group of patients in relation to whom will be applied the traditional method of recovery from anesthesia. In this group during the period of awakening we stop supplying sevoflurane and extubate patient after recovery of muscle tone, spontaneous breathing and consciousness.

Interventions

WashIn /WashOut PROCEDURE

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent from participants
• Age ≥ 18 years
• Planned open abdominal surgery
• General anesthesia

You may not qualify if:

• Pregnant patients and breastfeeding patients
• Mental disorders
• Epilepsy, Parkinson disease, Alzheimer, peripheral nerve and neuromuscular junction pathology (amyotrophic lateral sclerosis, Guillain-Barre Syndrome, myasthenia gravis et cet.)
• Use of antidepressants, antipsychotics, sedatives, psychoactive drugs within a month before surgery.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (3)

Moscow Scientific Clinical Center

Moscow, 111123, Russia

Location

Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Moscow, 129110, Russia

Location

Clinical hospital №1 of the I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

Location

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Study Officials

• Valery Likhvantsev

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

  STUDY DIRECTOR

• Giovanni Landoni

  San Raffaele Scientific Institute

  STUDY CHAIR

• Pavel Bagdasarov

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 21, 2021
• Study Start: March 10, 2021
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)