Effect of Mannitol on Propofol Level
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mannitol, Saline.
- Who it may be relevant to
- Registry conditions: Mannitol Adverse Reaction. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Propofol Level at TCI During Mannitol
Overview
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.
Detailed description
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.
Interventions
- Drug mannitol
2.5 mg/kg Mannitol will be given intravenously - Other Saline
2.5 ml/kg saline will be given as plasebo
Primary outcome measures
- Serum propofol levels [Time frame: Blood samples will take at intraoperatif period during total intravenous anesthesia (TIVA). (Till the 100th minutes of anesthesia)]
Secondary outcome measures (1)
- Urine propofol levels [Time frame: The sample collection will continue till the 100th minutes of anesthesia (TIVA)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Çukurova University — Çukurova
Identifiers
NCT: NCT06884657 · mannitol · Anesthesia