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NCT Number: NCT06884657

Effect of Mannitol on Propofol Level

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Çukurova University

Çukurova, Adana, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ebru Biricik

CONTACT

[email protected]

05052420223

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

2.5 mg/kg Mannitol will be given intravenously

Saline

Other

2.5 ml/kg saline will be given as plasebo

Primary outcomes

  1. Serum propofol levels

    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.

Secondary outcomes

  1. Urine propofol levels

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ebru Biricik

CONTACT

[email protected]

+905052420223

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Propofol Level at TCI During Mannitol

Acronym: level

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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