Effect of Mannitol on Propofol Level

NCT06884657 | Recruiting Phase 4

• 2 other identifiers: mannitolAnesthesia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mannitol Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Urine propofol levels

  The sample collection will continue till the 100th minutes of anesthesia (TIVA)

Study Arms (2)

Mannitol

ACTIVE COMPARATOR

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

Saline

PLACEBO COMPARATOR

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

Interventions

mannitol DRUG

2.5 mg/kg Mannitol will be given intravenously

Mannitol

Saline OTHER

2.5 ml/kg saline will be given as plasebo

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist (ASA) II participants
• supratentorial tumor surgery
• eligible for mannitol use
• eligible for Total intravenous anesthesia (TIVA)

You may not qualify if:

• American Society of Anesthesiologist (ASA) III and upper
• Chronic kidney failure
• sepsis
• multiorgan failure

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Çukurova University

Çukurova, Adana, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Mannitol; Sodium Chloride

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Ebru Biricik

CONTACT

+905052420223; ebrubiricik01@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 19, 2025
• Study Start: March 20, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 30, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)