Postoperative Delirium Clinical Trial
— OPERAOfficial title:
WashIn /WashOut Procedure To Prevent Agitation During Recovery After Inhalational Anesthesia With Sevoflurane: A Multicentral Randomized Trial
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Clinical hospital ?1 of the I.M. Sechenov First Moscow State Medical University (Sechenov University) | Moscow | |
Russian Federation | Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy | Moscow | |
Russian Federation | Moscow Scientific Clinical Center | Moscow |
Lead Sponsor | Collaborator |
---|---|
I.M. Sechenov First Moscow State Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | To estimate changes in the incidence of postoperative delirium on the scales CAM-ICU, ICDSC | incidence of postoperative delirium in control group - incidence of postoperative delirium in study group | 3 days after surgery twice a day (a.m. and p.m.) | |
Secondary | To estimate changes in the incidence of postoperative cognitive impairment | incidence of postoperative cognitive impairment in control group - incidence of postoperative cognitive impairment in study group | on the 7th day after surgery | |
Secondary | To estimate the incidence of postoperative nausea and vomiting, the need of using of antiemetics | incidence of postoperative nausea and vomiting, the need of using of antiemetics in control group - incidence of postoperative nausea and vomiting, the need of using of antiemetics in study group | Since end of surgery prior to hospital discharge | |
Secondary | To estimate patient satisfaction with anesthesia on the ISAS scale | Result of The Iowa Satisfaction with Anesthesia Scale (ISAS) | At third postoperative day | |
Secondary | Length of stay in ICU | The date of ICU discharged - the date of surgery | ICU discharged | |
Secondary | The duration of hospitalization | The date of hospital discharged - the date of surgery | Hospital discharged |
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