How mannitol affects propofol levels during brain surgery
Propofol Level at TCI During Mannitol
This study will test whether giving mannitol changes blood and urine propofol levels in adults having supratentorial tumor or pituitary surgery under total intravenous anesthesia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cukurova University Academic / other |
| Locations | 1 site (Çukurova, Adana) |
| Trial ID | NCT06884657 on ClinicalTrials.gov |
What this trial studies
Forty adults (20 per group) undergoing supratentorial tumor or pituitary surgery at Çukurova University will be enrolled. All patients will receive target-controlled infusions set to propofol 4 µg/dl and remifentanil 2–4 µg/dl; the mannitol group will receive 2.5 ml/kg (0.5 g/kg) mannitol 20 minutes after induction over 10 minutes while the control group receives 2.5 ml/kg isotonic saline over 10 minutes. Blood and urine samples will be collected to measure propofol concentrations, and invasive hemodynamic monitoring plus bispectral index (BIS) will be recorded for all participants. Key exclusions include chronic kidney failure, sepsis, multiorgan failure, or ASA class III and above.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with ASA II who are scheduled for supratentorial tumor or pituitary surgery and who are eligible for total intravenous anesthesia and mannitol where indicated.
Not a fit: Patients with ASA III or higher, chronic kidney failure, sepsis, or multiorgan failure would not be expected to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, results could help anesthesiologists adjust propofol dosing when mannitol is used, reducing the risk of over- or under-sedation.
How similar studies have performed: There is limited prior research directly measuring how mannitol affects propofol concentrations, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologist (ASA) II participants * supratentorial tumor surgery * eligible for mannitol use * eligible for Total intravenous anesthesia (TIVA) Exclusion Criteria: * American Society of Anesthesiologist (ASA) III and upper * Chronic kidney failure * sepsis * multiorgan failure
Where this trial is running
Çukurova, Adana
- Çukurova University — Çukurova, Adana, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ebru Biricik
- Email: ebrubiricik01@gmail.com
- Phone: +905052420223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.