Comparison of Two Different Anesthetic Techniques on Incidence of Postoperative Delirium in Cancer Patients After Laparoscopic Surgery in Trendelenburg Position: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Confusion Assessment Method in association with Richmond Agitation Sedation Scale will be used to postoperative delirium diagnosis.
研究概览
简要总结
Postoperative delirium is an acute mental syndrome that is caused by diffuse cerebral dysfunction resulting from the action of predisposing and precipitating factors acting together. It is associated with an increase in mortality and postoperative morbidity and prolongs the period of hospitalization of the patient Videolaparoscopic surgery has been increasingly used as a therapeutic and diagnostic method. In order to have a good visualization of the anatomical structures on which it will act, it is necessary to introduce gas into the cavity, a mandatory component known as pneumoperitoneum. This technique gives special characteristics for the conduction of anesthesia, since the positive intra-abdominal pressure results in changes in the patient's physiology. Some types of laparoscopic surgery require the position of Trendelenburg for better visualization of the operative field. Among the changes related to this position are the increase in cardiac output and intracranial pressure.
In order to optimize the anesthetic procedure, anesthetic blocks have been increasingly used, especially the spinal. The association of general anesthesia with spinal anesthesia, followed by its contraindications is advantageous, because lower doses of anesthetic agents are necessary for the maintenance of general anesthesia. This association results in an earlier awakening, a reduction of nausea / vomiting, postoperative pain, length of hospital stay, cost effectiveness and greater patient satisfaction. As a disadvantage, by associating general anesthesia with spinal anesthesia, patients become susceptible to the adverse events of spinal anesthesia. Among these, the most common are headache, hypotension, nausea and vomiting, pruritus, urinary retention and tremor. Performing spinal anesthesia with opioids alone, without the use of local anesthetic is also possible, with morphine being the most used. The benefit of this variation of technique is analgesia for a period of 12 to 24 hours, without the cardiovascular consequences resulting from the action of the local anesthetic.
JUSTIFICATION: There are no studies in the literature evaluating The objective of this study is to analyze if the anesthetic techniques employed, general anesthesia or general anesthesia associated with subarachnoid block, for videolaparoscopic oncologic surgeries, in Trendelenburg position, differ in relation to the incidence of delirium in the postoperative period.
详细描述
Patients will be allocated sequentially in 2 groups. Sequential allocation will be used in order to control age as a possible confounding factor for the outcome of interest.
These patients will be monitored intraoperatively with electrocardiogram (ECG), noninvasive pressure, pulse oximetry, capnography, BIS, monitor of neuromuscular blocker (TOF), esophageal temperature and Trendelenburg angle.
The measured moments will be patient entry in the operating room, after pre-anesthetic medication, anesthetic pre-induction, after anesthetic induction, after surgical incision, after pneumoperitoneum infusion, after Trendelenburg position, every 15 minutes until the end of the procedure and after extubation.
All patients will receive morphine 50 mcg via the spinal route. All patients will receive intravenous pre-anesthetic medication midazolam 0.03 mg / kg for comfort during spinal anesthesia and 500 ml of crystalloid solution prior to blockade associated with 4 ml / kg / hour of crystalloid solution plus volume to be depended of clinical parameters.
Subarachnoid block will be performed in the seated position, antisepsis / asepsis with alcoholic chlorhexidine, location of the L3 / L4 space, needle puncture with whitacre 27 G, barbotation of 0.5 ml and injection lasting 5 to 7 seconds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Oncologic patients submitted to elective videolaparoscopic surgery in Trendelenburg position
- •18 years or older
- •ASA lesser than 3
- •period of at least 2 hours in Trendelenburg position
排除标准
- •With absolute contraindication and related to spinal anesthesia
- •With difficult airway prediction with possibility of awake intubation.
- •With previous diagnosis of: cognitive disorder and / or depression.
- •Chronic use of benzodiazepines (use during the last 12 weeks).
- •Referred to perform the postoperative ICU.
- •With diagnosis of anemia (Hemoglobin <10).
- •With diagnosis of current infection.
- •With renal disease with stage> G3a (glomerular filtration rate <45 ml / min / 1.73 m
- •With body mass index (BMI) characterized by obesity (BMI> 30 kg / m2).
- •With history of nausea / vomiting in previous anesthetic procedures.
- •With diagnosis of malignant hyperthermia.
研究组 & 干预措施
Subarachnoid block
Subarachnoid block with hyperbaric bupivacaine 0,5% 3ml associate with morphine 50 mcg.
A general anesthetic with fentanyl 3 mcg / kg + propofol 2 mg / kg + rocuronium 0.6 mg / kg will be performed.
Anesthesia will be maintained with remifentanil (ng / ml) through Minto's pharmacokinetic model (BBraun infusion syringe - Perfusor® Space model) and desflurane (Fe%).
干预措施: Subarachnoid block (Procedure)
Spinal morphine
Spinal morphine with morphine 50 mcg. A general anesthetic with fentanyl 3 mcg / kg + propofol 2 mg / kg + rocuronium 0.6 mg / kg will be performed.
Anesthesia will be maintained with remifentanil (ng / ml) through Minto's pharmacokinetic model (BBraun infusion syringe - Perfusor® Space model) and desflurane (Fe%).
干预措施: Spinal morphine (Procedure)
结局指标
主要结局
Confusion Assessment Method in association with Richmond Agitation Sedation Scale will be used to postoperative delirium diagnosis.
时间窗: Until discharge from hospital (an average of 3 days)
Confusion Assessment Method: presence or absence of delirium If present should be classified Richmond Agitation Sedation Scale (positive):4 Combative; 3 Very agitated; 2 Agitated;1 Restless 0 Alert and calm (negative):1Drowsy;2 Light sedation; 3 Moderate sedation;4 Deep sedation;5 Unarousable (positive) delirium hyperactive (negative) delirium hypoactive
次要结局
- Numeric Pain Rating Scale will be used to evaluate pain.(Until discharge from hospital (an average of 3 days))
