Mannitol Adverse ReactionPhase 4levelNCT06884657
Effect of Mannitol on Propofol Level
A Phase 4 study testing mannitol and Saline in people with Mannitol Adverse Reaction, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mannitol Adverse Reaction
- What is being tested?
- mannitol and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2025to 30 Oct 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist (ASA) II participants
- supratentorial tumor surgery
- eligible for mannitol use
- eligible for Total intravenous anesthesia (TIVA)
Who cannot join
- American Society of Anesthesiologist (ASA) III and upper
- Chronic kidney failure
- sepsis
- multiorgan failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Çukurova University
Çukurova, Adana
Ebru Biricik, 05052420223, ebrubiricik01@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Mannitol Adverse Reaction
- Being tested
- mannitol, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mannitolDrug
2.5 mg/kg Mannitol will be given intravenously
SalineOther
2.5 ml/kg saline will be given as plasebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum propofol levels
Blood samples will be taken during study and then propofol levels will measure at the end of study.
Measured: 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.
Measured: The sample collection will continue till the 100th minutes of anesthesia (TIVA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start20 Mar 2025
- Primary completion20 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mannitol Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru biricik, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884657
- Sponsor's protocol ID
- mannitol
- Other IDs
- Anesthesia
- Acronym
- level
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Level at TCI During Mannitol
- ClinicalTrials.gov ID
- NCT06884657
- Acronym / sponsor ID
- level / mannitol
- Conditions
- Mannitol Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mannitol | Active comparator | Drug: mannitol2.5 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 | Placebo comparator | Other: Saline2.5 ml/kg saline will be given to patients 15 minutes after induction and the infusion will be adjusted to be 10 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologist (ASA) II participants
- supratentorial tumor surgery
- eligible for mannitol use
- eligible for Total intravenous anesthesia (TIVA)
Key exclusion criteria (4 listed)
- American Society of Anesthesiologist (ASA) III and upper
- Chronic kidney failure
- sepsis
- multiorgan failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mannitol2.5 mg/kg Mannitol will be given intravenously | Drug | Mannitol |
| Saline2.5 ml/kg saline will be given as plasebo | Other | Saline |
Primary outcome
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.
1 secondary outcome
Urine propofol levels
Time frame: The sample collection will continue till the 100th minutes of anesthesia (TIVA)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mannitol and Saline in people with Mannitol Adverse Reaction, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebru Biricik (+905052420223, ebrubiricik01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum propofol levels (time frame: Blood samples will take at intraoperatif period during total intravenous anesthesia (TIVA). (Till the 100th minutes of anesthesia)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025; AzTrials last refreshed its copy on 28 Oct 2026.