Çukurova University
Çukurova, Adana, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT06884657
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 4
Çukurova, Adana, Turkey (Türkiye)
Location status: Recruiting
The participants will divide into the two groups. 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, (Mannitol group) and Group 2 will include 20 patients who will undergo pituitary surgery without mannitol (Control Group). 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. Beside to standard monitoring invasive hemodynamic monitorization (cardiac output, cardiac index, stroke volume variability) and bispectral index will apply to the all participants.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2.5 mg/kg Mannitol will be given intravenously
2.5 ml/kg saline will be given as plasebo
Time frame: Blood samples will take at intraoperatif period during total intravenous anesthesia (TIVA). (Till the 100th minutes of anesthesia)
Blood samples will be taken during study and then propofol levels will measure at the end of study.
Time frame: The sample collection will continue till the 100th minutes of anesthesia (TIVA)
Urine samples will take during total intravenous anesthesia (TIVA). And then urine propofol levels will measure.
Contact information is provided by the study sponsor or research team.
Cukurova University
Other
Propofol Level at TCI During Mannitol
Acronym: level
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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