Brain TumorNCT01048684
Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy
A study testing Mannitol in people with Brain Tumor and Intracranial Pressure, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Neuroanesthesia for supratentorial surgery involves a thorough understanding of the physiopathology of intracranial pressure, cerebral homeostasis and regulation of cerebral perfusion pressure as well as the effects of anesthesia and surgery on these elements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Intracranial Pressure
- What is being tested?
- Mannitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older
- Patients who are to undergo an elective supratentorial craniotomy
- Physical status ASA I to IV inclusive.
Who cannot join
- Pregnancy
- Severe congestive heart failure
- Severe chronic renal failure
- Recent use (less than 24 hours before surgery)of mannitol or other hypertonic solution
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1
About this study
Neuroanesthesia for supratentorial surgery involves a thorough understanding of the physiopathology of intracranial pressure, cerebral homeostasis and regulation of cerebral perfusion pressure as well as the effects of anesthesia and surgery on these elements.
The main objective of anesthesia during neurosurgery is to preserve the integrity of the brain by maintaining cerebral homeostasis, and assuring cerebral protection using normovolemia, normotension, normoglycemia, moderate hyperoxia and hypocapnia and hyperosmolality with the administration of mannitol.
Read more
During surgery, the use of surgical retractors must be limited to avoid possible ischemia of the brain tissue. Surgical retractors can be replaced by chemical retractors. The concept of chemical retraction involves a reduction of cerebral blood flow, maintaining cerebral perfusion pressure, moderate hyperventilation, drainage of cerebrospinal fluid and osmotherapy.
Mannitol, an osmotic agent, has been widely used to reduce the volume of the brain, the intracranial pressure and to facilitate the surgical approach in reducing the risk of cortical lesions during the opening of the skull.
Mannitol 20% is usually given intravenously in bolus doses of 0.5-1g/kg over 30 minutes. However, over the last few years, the concept of a dose-response relationship has emerged. Some recent studies tend to demonstrate that higher doses of mannitol could reduce intracranial pressure significantly without any important side effects.
The main objective of the present study is to compare two doses of mannitol (0.7 and 1.4 g/kg) on brain relaxation during supratentorial craniotomies.
Read the detailed description
80 patients will be divided in two equal groups (Group 1: to receive 20% mannitol 0.7 g/kg or Group 2: 1.4 g/kg).
The anesthetic technique and monitoring will be standardized. The administration of mannitol will start following the induction of general anesthesia. The infusion will be given intravenously over 30 minutes.
Brain relaxation will be assessed by a senior surgeon at the opening of the dura mater on a scale from 1 to 4 (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain)
If needed, in case of significant cerebral edema, a rescue dose of 20% mannitol 0.25 g/kg will be administered.
Hemodynamic variables (MAP, heart rate), temperature, urine output, perioperative fluid balance, blood loss and laboratory values (blood gases, electrolytes, osmolality, hematocrit, glycemia, lactates) will be collected immediately prior to the infusion of mannitol and at 30, 60, 180 minutes following the administration of mannitol.
The type of cerebral lesion, its location and size (in 3 dimensions) will be noted. The presence of a median-line shift will also be assessed.
- Conditions
- Brain Tumor, Intracranial Pressure
- Being tested
- Mannitol
- Keywords
- Brain tumor, Intracranial pressure
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
Variation of mannitol dose
MannitolDrug
Variation of mannitol dose
| Study group | Role | What they receive |
|---|---|---|
| 20% Mannitol 0.7 g/kg (low-dose) | Active comparator | Study subjects will be randomized to receive an infusion of 20% mannitol 0.7g/kg over 30 minutes after induction of general anesthesia. Receives: Drug: Mannitol |
| 20% Mannitol 1.4 g/kg (high dose) | Experimental | Study subjects will be randomized to receive an infusion of 20% mannitol 1.4 g/kg over 30 minutes after induction of general anesthesia. Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain relaxation at the opening of the dura mater assessed by a senior surgeon on a scale from 1 to 4 (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain)
Measured: At the opening of the dura mater
Secondary outcomes (5)
Hemodynamic variables: MAP, heart rate
Measured: Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Temperature
Measured: Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Urine output
Measured: Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Perioperative fluid balance and blood loss
Measured: Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Laboratory data: blood gases, electrolytes, osmolality, hematocrit, glycemia, lactates
Measured: Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- François Girard, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048684
- Sponsor's protocol ID
- FG2010-003
- Status last verified
- May 2011
- First submitted
- 13 Jan 2010
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy
- ClinicalTrials.gov ID
- NCT01048684
- Acronym / sponsor ID
- FG2010-003
- Conditions
- Brain Tumor, Intracranial Pressure
- Keywords
- Brain tumor, Intracranial pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Jan 2010 (estimated)
- 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.
Neuroanesthesia for supratentorial surgery involves a thorough understanding of the physiopathology of intracranial pressure, cerebral homeostasis and regulation of cerebral perfusion pressure as well as the effects of anesthesia and surgery on these elements.
The main objective of anesthesia during neurosurgery is to preserve the integrity of the brain by maintaining cerebral homeostasis, and assuring cerebral protection using normovolemia, normotension, normoglycemia, moderate hyperoxia and hypocapnia and hyperosmolality with the administration of mannitol.
During surgery, the use of surgical retractors must be limited to avoid possible ischemia of the brain tissue. Surgical retractors can be replaced by chemical retractors. The concept of chemical retraction involves a reduction of cerebral blood flow, maintaining cerebral perfusion pressure, moderate hyperventilation, drainage of cerebrospinal fluid and osmotherapy.
Mannitol, an osmotic agent, has been widely used to reduce the volume of the brain, the intracranial pressure and to facilitate the surgical approach in reducing the risk of cortical lesions during the opening of the skull.
Mannitol 20% is usually given intravenously in bolus doses of 0.5-1g/kg over 30 minutes. However, over the last few years, the concept of a dose-response relationship has emerged. Some recent studies tend to demonstrate that higher doses of mannitol could reduce intracranial pressure significantly without any important side effects.
The main objective of the present study is to compare two doses of mannitol (0.7 and 1.4 g/kg) on brain relaxation during supratentorial craniotomies.
Detailed description
80 patients will be divided in two equal groups (Group 1: to receive 20% mannitol 0.7 g/kg or Group 2: 1.4 g/kg).
The anesthetic technique and monitoring will be standardized. The administration of mannitol will start following the induction of general anesthesia. The infusion will be given intravenously over 30 minutes.
Brain relaxation will be assessed by a senior surgeon at the opening of the dura mater on a scale from 1 to 4 (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain)
If needed, in case of significant cerebral edema, a rescue dose of 20% mannitol 0.25 g/kg will be administered.
Hemodynamic variables (MAP, heart rate), temperature, urine output, perioperative fluid balance, blood loss and laboratory values (blood gases, electrolytes, osmolality, hematocrit, glycemia, lactates) will be collected immediately prior to the infusion of mannitol and at 30, 60, 180 minutes following the administration of mannitol.
The type of cerebral lesion, its location and size (in 3 dimensions) will be noted. The presence of a median-line shift will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20% Mannitol 0.7 g/kg (low-dose) | Active comparator | Drug: MannitolStudy subjects will be randomized to receive an infusion of 20% mannitol 0.7g/kg over 30 minutes after induction of general anesthesia. |
| 20% Mannitol 1.4 g/kg (high dose) | Experimental | Drug: MannitolStudy subjects will be randomized to receive an infusion of 20% mannitol 1.4 g/kg over 30 minutes after induction of general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 or older
- Patients who are to undergo an elective supratentorial craniotomy
- Physical status ASA I to IV inclusive.
Key exclusion criteria (4 listed)
- Pregnancy
- Severe congestive heart failure
- Severe chronic renal failure
- Recent use (less than 24 hours before surgery)of mannitol or other hypertonic solution
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 |
|---|---|---|
| MannitolVariation of mannitol dose | Drug | 20% Mannitol 0.7 g/kg (low-dose) |
| MannitolVariation of mannitol dose | Drug | 20% Mannitol 1.4 g/kg (high dose) |
Primary outcome
Brain relaxation at the opening of the dura mater assessed by a senior surgeon on a scale from 1 to 4 (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain)
Time frame: At the opening of the dura mater
5 secondary outcomes
Hemodynamic variables: MAP, heart rate
Time frame: Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Temperature
Time frame: Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Urine output
Time frame: Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Perioperative fluid balance and blood loss
Time frame: Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Laboratory data: blood gases, electrolytes, osmolality, hematocrit, glycemia, lactates
Time frame: Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
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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. This study is not recruiting at the moment.
François Girard, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mannitol in people with Brain Tumor and Intracranial Pressure, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 5 May 2011. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain relaxation at the opening of the dura mater assessed by a senior surgeon on a scale from 1 to 4 (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain) (time frame: At the opening of the dura mater). 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 5 May 2011.