The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- postoperative cognitive disfunction
研究概览
简要总结
This study evaluates the influence of premedication on cognitive functions in patients undergoing transurethral resection of bladder tumor under spinal anesthesia. The aims of premedication are anxiolysis, analgesia and the reduction of perioperative risk among the patients with comorbidities. The patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is standardized.
详细描述
Trans-urethral resection of bladder tumor (TURBT) is the basic endoscopic procedure for management of bladder cancer and if there are no contraindications, it is performed under spinal anesthesia. The condition usually occurs among elderly patients, every 9 of 10 is older than 55 years. At this age the postoperative cognitive dysfunction (POCD) is a common complication as the risk increases with age. There are some studies indicating that using benzodiazepines during the perioperative period can also increase the number of registered POCD in patients undergoing anesthesia. Postoperative cognitive dysfunction (POCD) occurs after operations under regional and general anesthesia as well. The study was planed to evaluate the risk of POCD among urological patients and to asses whether combining benzodiazepines with opioids for premedication increases this risk.
The participants after giving the informed consent can participate in the study. The Beck Depression Inventory is performed to rule out the patients with depression. The cognitive functions are tested with Montreal Cognitive Assessment before the surgery and subsequently in the first 24 hours after surgery, three weeks later (while patients come back to receive histopathological examination), and finally six months after surgery (during control cystoscopy).
During anesthesia, the patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is standardized. If the premedication is needed before the surgery the hydroxyzine will be administrated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
the participant is not performed about the type of premedication performed
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
- •informed consent
- •transurethral resection of the bladder tumor
- •spinal anesthesia
排除标准
- •Exclusion Criteria:
- •patients' refusal
- •contraindications for spinal anesthesia
- •skin lesions at injection site
- •depression
研究组 & 干预措施
Group B
spinal anesthesia premedication with benzodiazepine and opioid
干预措施: benzodiazepines (Drug)
Group B
spinal anesthesia premedication with benzodiazepine and opioid
干预措施: opioid (Drug)
Group B
spinal anesthesia premedication with benzodiazepine and opioid
干预措施: spinal anesthesia (Procedure)
Group K
spinal anesthesia premedication with opioid
干预措施: opioid (Drug)
Group K
spinal anesthesia premedication with opioid
干预措施: spinal anesthesia (Procedure)
结局指标
主要结局
postoperative cognitive disfunction
时间窗: 6 months
evaluated by Montreal Cognitive Assesment
次要结局
- the influence of benzodiazepines on POCD(6 months)
研究者
Karolina Dobrońska
MD
Medical University of Warsaw
