Perioperative antimicrobial drug penetration into the cerebrospinal fluid in extended transsphenoidal surgery

JRCT ID: jRCTs031220108

Registered date:02/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patient undergoing extended transsphenoidal surgery with lumbar drainage
• Date of first enrollment: 31/10/2022
• Target sample size: 10
• Study type: Interventional

Intervention(s)

1) Preoperative administration: After insertion of lumbar drainage, 2 g of CTRX should be administered intravenously over 30 minutes to 1 hour (single dose), starting within 1 hour before the start of surgery. Intraoperative re-dose should be 12 hours after the initial dose; however, patients who re-dose will be dropped from the study (see Discontinuation Criteria).
2) Postoperative administration: 2 g of CTRX is administered once daily (every 24 hours) as an intravenous infusion over 30 minutes to 1 hour. The duration of administration should be up to day 7 (the day after surgery should be day 1).

Outcome(s)

• Primary Outcome: CSF/blood concentration ratio of CTRX on day 1
• Secondary Outcome: The maximum concentration in CSF and blood, time to reach maximum concentration and half-life, trends in CTRX concentration in CSF, daily trends in CSF/blood concentration ratio of CTRX, CSF/blood ALB ratio and CTRX CSF migration, an association between surgical invasion and CTRX CSF migration, an association between surgery time and CSF migration, an association between general findings in CSF and CTRX CSF migration, blood inflammation findings and CTRX CSF migration, intraoperative CSF leakage score and CTRX CSF migration, BMI and CTRX CSF migration, antipyretic analgesics and CTRX CSF migration, time above the MIC for CTRX in CSF, CTRX assay

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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)

Exclude criteria

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

Related Information

• Primary Sponsor: Sugii Narushi
• Source(s) of Monetary Support: University of Tsukuba Hospital