Procedure to Reduce Agitation After Inhalational Anesthesia
WashIn /WashOut Procedure To Prevent Agitation During Recovery After Inhalational Anesthesia With Sevoflurane: A Multicentral Randomized Trial
NA · I.M. Sechenov First Moscow State Medical University · NCT04765488
This study tests a new method to see if it can help adults recovering from surgery under general anesthesia feel less agitated and recover more smoothly.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | I.M. Sechenov First Moscow State Medical University (other) |
| Locations | 3 sites (Moscow and 2 other locations) |
| Trial ID | NCT04765488 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a WashIn/WashOut procedure aimed at preventing agitation during recovery from inhalational anesthesia with sevoflurane. Agitation is a common complication that can lead to longer recovery times and increased risk of postoperative delirium and cognitive dysfunction. The study will involve adult patients undergoing planned open abdominal surgery under general anesthesia. Participants will be monitored for agitation levels and other postoperative outcomes following the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for open abdominal surgery and will receive general anesthesia.
Not a fit: Patients with mental disorders, neurological conditions, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could significantly improve recovery experiences and outcomes for patients undergoing surgery.
How similar studies have performed: While there have been attempts to address postoperative agitation, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent from participants 2. Age ≥ 18 years 3. Planned open abdominal surgery 4. General anesthesia Exclusion Criteria: 1. Pregnant patients and breastfeeding patients 2. Mental disorders 3. Epilepsy, Parkinson disease, Alzheimer, peripheral nerve and neuromuscular junction pathology (amyotrophic lateral sclerosis, Guillain-Barre Syndrome, myasthenia gravis et cet.) 4. Use of antidepressants, antipsychotics, sedatives, psychoactive drugs within a month before surgery.
Where this trial is running
Moscow and 2 other locations
- Moscow Scientific Clinical Center — Moscow, Russian Federation (RECRUITING)
- Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy — Moscow, Russian Federation (RECRUITING)
- Clinical hospital №1 of the I.M. Sechenov First Moscow State Medical University (Sechenov University) — Moscow, Russian Federation (RECRUITING)
Study contacts
- Principal investigator: Pavel Bagdasarov — I.M. Sechenov First Moscow State Medical University (Sechenov University)
- Study coordinator: Valery Likhvantsev
- Email: lik0704@gmail.com
- Phone: +7903-623-5982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Agitation, Emergence, Postoperative Delirium, Postoperative Cognitive Dysfunction, emergence agitation, postoperative agitation, postoperative delirium, postoperative cognitive dysfunction