Effect of Mannitol on Propofol Level

Phase 4

Not yet recruiting

• Conditions: Mannitol Adverse Reaction
• Interventions: Drug: mannitol; Other: Saline

• Registration Number: NCT06884657
• Lead Sponsor: Cukurova University

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 15 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 15 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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Study Start: 2025-03-20
• Primary Completion: 2025-05-20
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mannitol	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.
Saline	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.

Primary Outcome Measures

Name	Time	Method
Serum propofol levels	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 Outcome Measures

Name	Time	Method
Urine propofol levels	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.