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Effect of Mannitol on Propofol Level

ConditionMannitol Adverse Reaction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCukurova University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologist (ASA) II participants

supratentorial tumor surgery

eligible for mannitol use

eligible for Total intravenous anesthesia (TIVA)

Disqualifiers

American Society of Anesthesiologist (ASA) III and upper

Chronic kidney failure

sepsis

multiorgan failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • mannitol

    Drug

    2.5 mg/kg Mannitol will be given intravenously

  • Saline

    Other intervention

    2.5 ml/kg saline will be given as plasebo

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: MannitolActive comparator 1 intervention
Group B: SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serum propofol levels

Blood samples will be taken during study and then propofol levels will measure at the end of study.

Time frame
Blood samples will take at intraoperatif period during total intravenous anesthesia (TIVA). (Till the 100th minutes of anesthesia)

Secondary outcomes

1

Urine propofol levels

Urine samples will take during total intravenous anesthesia (TIVA). And then urine propofol levels will measure.

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Çukurova UniversityRecruiting Çukurova, AdanaTurkey (Türkiye)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cukurova University

Lead sponsor

Source ClinicalTrials.gov
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