Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Patients will receive a noninvasive measurement of ICP variations during each of their follow up consultation. These measurements will last until 30 minutes for the first consultation (parameters to determine) and 10 minutes for the others. A postural test will be performed during the ICP measurements when the patient condition will make it possible to do.

Measurements will be performed by a device with noninvasive acoustic probes placed in the ear, and in case of electrophysiological test, regular electrodes on the brow.

noninvasive method of ICP measurements (Elios)

Xavier DURANDO, MD

In patients at risk of increased intracranial pressure (ICP), ICP measurements require invasive transducers, usually with insertion of a catheter into the cranium, or through a spinal tap. These invasive modalities involve risks and pain and they can be done only in specialized care units, with a high associated cost.

A novel method for detecting changes in ICP has developed recently. The auditory hair cells emit sounds and electric signals in response to sound, which can be easily detected and measured non-invasively with the help of a microphone probe placed in the external ear canal or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF) spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within seconds.

A symptom of intracranial pressure (ICP) was observed in glioma patient due to a combination of causes: the inflammatory reaction around the tumor, the mass effect of the tumor, secondary vascular changes, a change in the flow of CSF.

The evaluation of intracranial hypertension by increased ICP (invasive) is not used in the monitoring of intracranial tumors. It is then detected by using routine clinical signs, in combination with a standard imaging method (MRI), but still subjective.

The measurement of noninvasive ICP could allow earlier detection of relapse, and evaluate whether the increase in ICP precedes tumor clinical worsening and / or imaging.

Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma

Presence of an ICP variation or increase when physician has diagnosed a clinical or morphological aggravation of the tumor with standard diagnose methods (composite outcome measure ) : clinical signs, MRI and response assessment in neuro-oncology criteria (RANO) .

Laboratoire de Biophysique Neurosensorielle - UMR INSERM 1107 (Pr Paul AVAN)

Centre Jean Perrin

Natriuretic Agents

All Drugs and Chemicals

Mannitol

Diuretics

20% mannitol bolus administration

Hypertonic saline 3% bolus administration

Stéphane Coutu, MD, FRCPC

Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and intensive care settings. More recent data indicate that hypertonic saline may be as effective or more effective than mannitol for this purpose, with possible fewer side effects.

This study compares both agents in favoring cerebral relaxation during elective supratentorial procedures for tumor resection.

Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer side effects than 20% mannitol.

Comparison of 20% Mannitol and 3% Hypertonic Saline for Cerebral Relaxation During Elective Supratentorial Craniotomies

Comparison of the Efficacy Between 20% Mannitol and 3% Hypertonic Saline, Given as a Bolus at the Beginning of Elective Supratentorial Craniotomy for Tumor Resection, in Favoring Cerebral Relaxation Evaluated by a Sub-dural Intracranial Pressure Measurement.

Sub-dural measure of intracranial pressure to evaluate cerebral relaxation

Subjective evaluation by the surgeon of cerebral relaxation on a 4 point scale

Serum lactate measurement to assess tissue perfusion during the procedure

Université de Sherbrooke

Principal study investigator

Nervous System Diseases

Heart and Blood Diseases

Wounds and Injuries

Brain Neoplasms

Stroke

Hypertension

Intracranial Hypertension

Brain Injuries

Hydrocephalus

Brain Diseases

Central Nervous System Diseases

Craniocerebral Trauma

Trauma, Nervous System

Central Nervous System Neoplasms

Nervous System Neoplasms

ICP readings will be recorded in parallel from both the invasive ICP monitor, and HeadSense's non-invasive ICP monitor. Each recording session will be done until an aggregate of at least 30 minutes worth of quality data is collected, depending on the patient's clinical condition. For each patient, two recording sessions will be completed for 30-60 minutes each for 120 minutes total.

HS-1000

Katsuji Shima

Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head.

HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.

A prospective study will be conducted on 80 patients with an inserted invasive intraparenchymal ICP monitor. Once a patient undergoes invasive ICP monitoring, has a life expectancy of greater than 48 hours and is 14 years old and over at the screening visit, and has an intact/continuous dura layer, the patient will become a candidate for enrollment into the study. If the patient signs the informed consent or the patient's legal authorized representative signs on the patient's behalf, the patient will be enrolled into the trial. Each enrolled patient will be monitored in parallel to the invasive ICP monitor with the HeadSense's device. Once the data collection is complete, results will be analyzed by comparing ICP readings from both devices.

The primary end-point of the study is to collect 60-120 minutes of ICP monitoring data over two sessions of 30-60 minutes each for 80 neurosurgery patients of any etiology. The secondary endpoint of this study is evaluate the safety of the device as measured by incidence of adverse events and serious adverse events over each subject's 96 hours of participation.

An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device

HeadSense Medical

Central Nervous System Depressants

Anesthetics

Study subjects will be randomized to receive an infusion of 20% mannitol 0.7g/kg over 30 minutes after induction of general anesthesia.

Study subjects will be randomized to receive an infusion of 20% mannitol 1.4 g/kg over 30 minutes after induction of general anesthesia.

François Girard, MD, FRCPC

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.

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.

Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy

Centre hospitalier de l'Université de Montréal (CHUM)

François Girard MD FRCPC

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Digestive System Diseases

Symptoms and General Pathology

Leiomyoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Myofibroma

Cholecystitis

Acalculous Cholecystitis

Cysts

Ovarian Cysts

Myoma

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endocrine System Diseases

Gonadal Disorders

Gallbladder Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Connective Tissue Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Analgesics

Other Dietary Supplements

Remifentanil

Desflurane

Benzocaine

Analgesics, Opioid

Narcotics

Anesthetics, Inhalation

Anesthetics, General

Tannic Acid

Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust minimum alveolar concentration (MAC) to maintain bispectral index (BIS) between 40-60

Drug: Remifentanil Adjuvant continuous administration

- adjust effect site concentration to maintain changes of vital sign below 20%

Device: Ultrasonographic measurement of ONSD

Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O.

Trendelenburg position - 30 degree

Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust MAC to maintain BIS between 40-60

Drug: Remifentanil Adjuvant continuous administration

- adjust effect site concentration to maintain changes of vital sign below 20%

Device: Ultrasonographic measurement of ONSD

Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O.

Reverse Trendelenburg position - 30 degree

Anesthesia with desflurane in both Group 1 and Group 2

- adjust MAC to maintain BIS between 40-60

Adjuvant continuous administration

- adjust effect site concentration to maintain changes of vital sign below 20%

Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area (4 cm deep) using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values.

Ultrasonographic measurement of ONSD

After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:2) using a tidal volume of 8-10 mL/kg and a respiratory rate of 10-12/min, and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O.

Mechanical ventilation

Trendelenburg position - 30 degree

Reverse Trendelenburg position - 30 degree

Ki Tae Jung, M.D.

Increase of intracerebral pressure (ICP) during laparoscopic surgery has known to be associated with positional changes. Optic nerve sheath diameter (ONSD) has correlation with ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to investigate the change of ONSD according to the positional change during laparoscopic surgery.

1. Purpose There can be many physiologic changes during laparoscopic surgery. Increase of intracerebral pressure (ICP) is one of them, which has known to be associated with arterial concentration of carbon dioxide or positional changes. Changes of ICP can be measured directly by invasive method. However, optic nerve sheath diameter (ONSD) has correlation with ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to investigate the change of ONSD according to the positional change during laparoscopic surgery.
2. Hypothesis Changes of ONSD will be shown according to the positional change during laparoscopic surgery, and these can reflect the changes of ICP.
3. Objectives Female patients who are scheduled to undergo laparoscopic surgery, American society of anesthesiologist class (ASA) I-II, aged between 19 to 65 years, are allocated into 2 groups.

   * Group 1: Laparoscopic gynecological surgery, (Trendelenburg position)
   * Group 2: Laparoscopic cholecystectomy, (Reverse trendelenburg position)
4. Methods Patients are premedicated with midazolam 0.5 mg/kg before transported to the operating room. Once in the operating room, patients were monitored with electrocardiography, non invasive blood pressure, pulse oximetry (Datex-Ohmeda S/5, Planar Systems, Inc., Beaverton, OR, USA) and BIS (Aspect 2000, Aspect Medical Systems, Inc., Newton, MA, USA).

   Anesthesia are induced with propofol (2mg/kg) and followed by administering rocuronium 0.6 mg/kg. After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:2) using a tidal volume of 8-10 mL/kg and a respiratory rate of 10-12/min, and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Anesthesia is maintained with desflurane in addition to the continuous infusion of remifentanil. Radial arterial cannulation is done for invasive arterial blood pressure monitoring.

   After induction of anesthesia, when stabilization of cardiovascular status is achieved, optic nerve sheath diameter (ONSD) is measured by ultrasonographic measurement. Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area (4 cm deep) using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values.

   ONSD was measured at 7 serial time points during surgery:
   1. Preinduction (prior to the induction of anesthesia in the operating room)
   2. 5 minutes after induction of anesthesia
   3. 5 minutes after introducing pneumoperitoneum
   4. 5 minutes after positional change
   5. 15 minutes after positional change
   6. 30 minutes after positional change
   7. 5 minutes after discontinuing pneumoperitoneum Arterial blood gas analysis is performed to evaluate the arterial carbon dioxide concentration (PaCO2) level at each time point.
5. Statistical Analysis All data are expressed as numbers (%) or mean ± standard deviation. Repeated measures ANOVA will be performed to compare the parameters at specific time points during surgery.

ONSD According to the Position During Laparoscopy

Comparison of Optic Nerve Sheath Diameter According to Position During Laparoscopy

ONSD - preinduction (prior to the induction of anesthesia in the operating room)

ONSD and PaCO2 - 5 minutes after induction of anesthesia

ONSD and PaCO2 - 15 min after positional change

ONSD and PaCO2 - 30 minutes after positional change

ONSD and PaCO2 - 5 minutes after discontinuing pneumoperitoneum

ONSD and PaCO2 - 5 minutes after introducing positional change

ONSD and PaCO2 - 5 minutes after introducing pneumoperitoneum

Chosun University Hospital

Assist professor

Supratentorial Neoplasms

Pharmaceutical Solutions

Administration of Hypertonic Solution 7.5% vs Mannitol 20%

Rosemary A Craen, MD

The purpose of this study is to evaluate the effect of Hypertonic Saline 7.5% vs Mannitol 20% on brain bulk (using a 4 point scale), intracranial pressure (subdural catheter)and the changes on serum and urinary Na, K and Osmolarity during elective craniotomy for brain tumor resection.

Raised intracranial pressure occurs following an expansion of an intracranial mass e.g. hematoma or brain tumor and if left untreated, can lead to brain ischemia, stroke and death.

Strategies for reducing raised intracranial pressure include hyperventilation, use of a hyperosmolar agent and the evacuation of the intracranial mass.

The two hypertonic solutions most commonly used are Mannitol 20% and Hypertonic Saline 7.5%.

During elective neurosurgical removal of a brain tumour, the anesthesiologist needs to reduce intracranial pressure and provide good operating brain conditions to avoid brain ischemia.

Currently, Mannitol 20% is routinely used intra-operatively in these patients to reduce brain bulk and intracranial pressure and to improve brain operating conditions.

However, Mannitol itself can cause secondary effects that can be deleterious to the neurological patient. Mannitol causes a diuresis which may lead to systemic hypovolemia and hypotension, and adverse changes in serum and urinary sodium, potassium and osmolarity.

Experience with Hypertonic saline 7.5%, has been mainly in brain injured patients either in the Emergency Dept or in the Intensive care setting. There is growing evidence that Hypertonic saline 7.5% is just as effective as Mannitol 20% in reducing raised intracranial pressure, especially in traumatic brain injury and it has become a widely accepted form of treatment. One of the advantages of Hypertonic saline is that it does not cause a diuresis and therefore less likely to cause hypotension and hypovolemia. While transient hypernatremia has been observed after the administration of hypertonic saline, there have been no clinical consequences.

Unfortunately there have been only two studies which compared the effectiveness of Hypertonic saline and Mannitol during elective brain surgery. One of them, Gemma et al, failed to demonstrate any difference in the reduction of brain bulk between Mannitol and Hypertonic saline. However the 2 solutions used had different osmolarities and this may have had a confounding effect on the results. In the other study (published in Polish), the authors found a 20% reduction in brain bulk in favour of hypertonic saline. In view of these two opposing findings, we feel that another investigation is warranted.

Hypertonic Saline 75% vs Mannitol 20%

Comparison of Equiosmolar Doses of Mannitol 20% Versus Hypertonic Saline 7.5% Infusion in the Reduction of Brain Bulk During Elective Craniotomies for Supratentorial Brain Tumor Resection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma	NCT02520492	Glioma	noninvasive met...	18 Years - 65 Years	Centre Jean Perrin
Comparison of 20% Mannitol and 3% Hypertonic Saline for Cerebral Relaxation During Elective Supratentorial Craniotomies	NCT01745081	Osmotherapy Intracranial Pr...	20% mannitol bo... Hypertonic sali...	18 Years -	Université de Sherbrooke
Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma	NCT02520492	Glioma	noninvasive met...	18 Years - 65 Years	Centre Jean Perrin
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device	NCT02773888	Intracranial Hy... Brain Injuries Stroke Hydrocephalus Brain Neoplasms	HS-1000	14 Years -	HeadSense Medical
Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy	NCT01048684	Brain Tumor Intracranial Pr...	Mannitol Mannitol	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
ONSD According to the Position During Laparoscopy	NCT01937104	Cholecystitis Ovarian Cyst Ovarian Cancer Uterine Myoma Cervical Cancer	Desflurane Remifentanil Ultrasonographi... Mechanical vent... Trendelenburg p... Reverse Trendel...	19 Years - 65 Years	Chosun University Hospital
Comparison of 20% Mannitol and 3% Hypertonic Saline for Cerebral Relaxation During Elective Supratentorial Craniotomies	NCT01745081	Osmotherapy Intracranial Pr...	20% mannitol bo... Hypertonic sali...	18 Years -	Université de Sherbrooke
ONSD According to the Position During Laparoscopy	NCT01937104	Cholecystitis Ovarian Cyst Ovarian Cancer Uterine Myoma Cervical Cancer	Desflurane Remifentanil Ultrasonographi... Mechanical vent... Trendelenburg p... Reverse Trendel...	19 Years - 65 Years	Chosun University Hospital
Hypertonic Saline 75% vs Mannitol 20%	NCT00199511	Brain Tumor Tumor, Brain Brain Neoplasm Neoplasm, Supra... Tumor, Supraten...	Administration ...	18 Years - 75 Years	Lawson Health Research Institute

Spots Global Cancer Trial Database for intracranial pressure