Effect of Mannitol on Propofol Level (level)

Propofol Level at TCI During Mannitol

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.

Study Overview

• Status: Recruiting
• Conditions: Mannitol Adverse Reaction
• Intervention / Treatment: Drug: mannitol; Other: Saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ebru Biricik; Phone Number: +905052420223; Email: ebrubiricik01@gmail.com

Study Locations

• Turkey (Türkiye)
  • Adana
    • Çukurova, Adana, Turkey (Türkiye)
      • Recruiting
      • Çukurova University
      • Contact: Ebru Biricik; Phone Number: 05052420223; Email: ebrubiricik01@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mannitol; 2.5 ml/kg (0.5 g/kg) Mannitol will be given to all patients 15 minutes after induction and the mannitol infusion will be adjusted to be 10 minutes.	Drug: mannitol; 2.5 mg/kg Mannitol will be given intravenously
Placebo Comparator: Saline; 2.5 ml/kg saline will be given to patients 15 minutes after induction and the infusion will be adjusted to be 10 minutes.	Other: Saline; 2.5 ml/kg saline will be given as plasebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum propofol levels	Blood samples will be taken during study and then propofol levels will measure at the end of study.	Blood samples will take at intraoperatif period during total intravenous anesthesia (TIVA). (Till the 100th minutes of anesthesia)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine propofol levels	Urine samples will take during total intravenous anesthesia (TIVA). And then urine propofol levels will measure.	The sample collection will continue till the 100th minutes of anesthesia (TIVA)

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): October 20, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Pharmaceutical Preparations; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Alcohols; Sugar Alcohols; Mannitol; Saline Solution
• Other Study ID Numbers: mannitol; Anesthesia (Registry Identifier: Çukurova University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No