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Effect of Mannitol on Propofol Level

Propofol Level at TCI During Mannitol

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06884657
Acronym
level
Enrollment
40
Registered
2025-03-19
Start date
2025-03-20
Completion date
2025-10-30
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mannitol Adverse Reaction

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.

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

DRUGmannitol

2.5 mg/kg Mannitol will be given intravenously

OTHERSaline

2.5 ml/kg saline will be given as plasebo

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum propofol levelsBlood 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.

Secondary

MeasureTime frameDescription
Urine propofol levelsThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactEbru Biricik
ebrubiricik01@gmail.com+905052420223

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026