NCT06884657 Effect of Mannitol on Propofol Level
| NCT ID | NCT06884657 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Cukurova University |
| Condition | Mannitol Adverse Reaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2025-10-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2025-03-20 with a primary completion date of 2025-10-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Group 1 will include 20 patients aged 18 years and over, American Society of Anesthesiologist (ASA) II-III class, who will undergo supratentorial tumor surgery, and Group 2 will include 20 patients who will undergo pituitary surgery without mannitol. Total intravenous anesthesia (TIVA) will be adjusted to propofol 4 µg/dl and remifentanil 2-4 µg/dl with target-controlled infusion pumps. In the mannitol group, 2.5 ml/kg (0.5 g/kg) will be given to all patients 20 minutes after induction and the mannitol infusion will be adjusted to be 10 minutes.In Group 2, mannitol will not be used and 2.5 ml/kg isotonic will be administered in 10 minutes. Both blood and urine samples will take for measurement to propofol levels.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06884657 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Mannitol Adverse Reaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06884657 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06884657 currently recruiting?
Yes, NCT06884657 is actively recruiting participants. Contact the research team at ebrubiricik01@gmail.com for enrollment information.
Where is the NCT06884657 trial being conducted?
This trial is being conducted at Çukurova, Turkey (Türkiye).
Who is sponsoring the NCT06884657 clinical trial?
NCT06884657 is sponsored by Cukurova University. The trial plans to enroll 40 participants.