JPRN-jRCTs031220108招募中未知
Clinical pharmacology study on perioperative antimicrobial drug penetration into the cerebrospinal fluid in extended transsphenoidal surgery
Sugii Narushi0 个研究点目标入组 10 人开始时间: 2022年6月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients scheduled for extended transsphenoidal surgery (emergency surgery is not applicable)
- •2) Patients who have lumbar drainage placed prior to surgery
- •3) Patients who will receive CTRX as a perioperative antimicrobial agent
- •4) Age 18 years or older on the date of consent, regardless of gender
- •5) Patients who have been informed of the contents of the study fully understand them and have given their free and voluntary written consent (substitute consent is not acceptable, but substitute writing is acceptable)
排除标准
- •1) Patients with a history of hypersensitivity to any component of the study drug
- •2) Patients with a history of hypersensitivity to cephem antibiotics
- •3) Patients with the highest suspicion of chordoma as a preoperative diagnosis
- •4) Patients with complications of systemic diseases or severe conditions that may interfere with the safe performance of general anesthesia or surgery
- •5) Patients with active sinusitis or known MRSA carriage in the nasal cavity
- •6) Patients with serious cardiovascular diseases (myocardial infarction, unstable angina, valvular disease, heart failure, etc.) require special attention in perioperative management
- •7) Patients with serious liver disease or abnormal liver enzymes [AST (GOT) or ALT (GPT) > 100 U/L]
- •8) Patients with severe renal dysfunction (serum creatinine > 1.5 mg/dL)
- •9) Positive for HBs antigen, HCV antibody, or HIV antibody
- •10) Pregnant women or women of childbearing potential
- •11) breast-feeding Women
- •12) Scheduled surgery time is more than 11.5 hours
- •13) Patients with hypersensitivity (including suspected hypersensitivity) to contrast media for MRI
- •14) Patients on immunosuppressive drugs or steroids (although steroid use for hormone replacement or perioperative steroid cover purposes is acceptable)
- •15) Patients who have received other study or investigational drugs for therapeutic purposes within three months of the scheduled administration of the study drug
- •16) Patients whom the investigators' judge to be ineligible as subjects
研究者
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