WashIn /WashOut Procedure To Prevent Agitation During Recovery After Inhalational Anesthesia With Sevoflurane: A Multicentral Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- The effect of "Wash In / WashOut" procedure on the incidence of postoperative agitation after anesthesia with sevoflurane.
研究概览
简要总结
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.
详细描述
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. Since alveolar concentrations of inhaled anesthetics correspond to their concentrations in other organs after equilibrium, which is most quickly achieved in organs with rich perfusion, such as the brain and heart, MAC is an analogue of the plasma EC50 (concentration effective at 50%) for intravenous anesthetics. 1 MAC of sevoflurane is equal to an end-tidal concentration of 2.0 volume percent.
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.).
Despite the fact that attempts to reduce the risk of postoperative neurological complications have been made repeatedly, the frequency of occurrence of agitation in the early post operative period in adult patients is up to 30%.
Some authors drew attention to the need to comply with the basic requirements for the safety of anesthesia: continuity and adequacy of anesthesia, and avoidance of excessively deep or too superficial level of anesthesia. Other authors consider it suitable to use midazolam, propofol, opioid and non-opioid analgesics in case of agitation. Magnesium and calcium chloride were also tested to stop the described phenomenon, but their beneficial effects were not confirmed in subsequent investigations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from participants
- •Age ≥ 18 years
- •Planned open abdominal surgery
- •General anesthesia
排除标准
- •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.
结局指标
主要结局
The effect of "Wash In / WashOut" procedure on the incidence of postoperative agitation after anesthesia with sevoflurane.
时间窗: during 30 minutes after awaking
the patient scores +2 or more points on the RASS scale in one or more measurements, then he is diagnosed with agitation.
To estimate changes in the incidence of postoperative agitation on the RASS scale
时间窗: during 30 minutes after awaking
incidence of postoperative agitation in control group - incidence of postoperative agitation in study group
次要结局
- To estimate patient satisfaction with anesthesia on the ISAS scale(At third postoperative day)
- 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.))
- The duration of hospitalization(Hospital discharged)
- 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)
- Length of stay in ICU(ICU discharged)