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临床试验/NCT03029676
NCT03029676Unknown4 期

The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

spinal anesthesia premedication with benzodiazepine and opioid

干预措施: benzodiazepines (Drug)

Group B

Experimental

spinal anesthesia premedication with benzodiazepine and opioid

干预措施: opioid (Drug)

Group B

Experimental

spinal anesthesia premedication with benzodiazepine and opioid

干预措施: spinal anesthesia (Procedure)

Group K

Active Comparator

spinal anesthesia premedication with opioid

干预措施: opioid (Drug)

Group K

Active Comparator

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

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karolina Dobrońska

MD

Medical University of Warsaw

研究点 (1)

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