None listed
Conditions
Brief summary
The present study aimed to compare that anti-edema effects of hypertonic saline and mannitol. Patients who are between 18-65 years old,who belonge to ASA I- III and who would have elective supratentorial tumour surgery will be included. Demographic features of the patients, medications, localization of the tumor, maximum diameter of the tumor measured by CT, volume of the tumor and level of midline shift will be recorded. Initial systolic arterial pressure, mean arterial pressure and diastolic arterial pressure will recorde. Patients will monitored for heart rate (HR) using five-channel ECG, noninvasive blood pressure, peripheral oxygen saturation (SpO2), end-tidal CO2 (ETCO2), state entropy (SE) using an entropy module, and train-of-four (TOF) using a neuromuscular transmission module. For anesthesia induction 1 mcg/kg fentanyl, 0.6mg/kg rocuronium bromure will administered and 1% propofol will be used until the SE value will be below 60. After surgery position, Surgeons will open a small hole (diameter is under 5 mm) to cranium. for inserting the intracranial pressure measurement (ICP) probe. Probe will be inserted immediately adjacent the tumor. Patients will seperated into two groups according to anti-edema treatment randomly as Mannitol group (Arm I) and Hypertonic Saline Group (Arm II). In Arm I: 20 % mannitol (with dose of 1gr/kg) will be given to patients in 15 minutes. In Arm II: 3% NACL (with ose of 5 ml / kg) will be given to patients in 15 minutes. Patients were examined during treatment and 30 minutes after anti-edema treatment and surgery not will begin unless examination finished. Patients' intracranial preasure, mean arterial preasure and state entropy values will be measured and recorded before treatment and every 1 minute until examination finished ( totaly 45 minute).
Interventions
Patients who were between 18-65 years old and who would have elective supratentorial tumour surgery will be included.After positioning the participant for surgery. Surgeons will open a small hole (diameter is under 5 mm) to cranium. for inserting the intracranial pressure measurement (ICP) probe.Probe will be inserted immediately adjacent the tumor.
Patients will be randomly allocated to an anti-edema treatment arm either Mannitol group (Arm I) and Hypertonic Saline Group (Arm II).
In Arm I: 20
Patients who were between 18-65 years old and who would have elective supratentorial tumour surgery will be included.After positioning the participant for surgery. Surgeons will open a small hole (diameter is under 5 mm) to cranium. for inserting the intracranial pressure measurement (ICP) probe.Probe will be inserted immediately adjacent the tumor. Patients will be randomly allocated to an anti-edema treatment arm either Mannitol group (Arm I) and Hypertonic Saline Group (Arm II). In Arm I: 20 % mannitol (with dose of 1gr/kg) will be given to patients as an intravenous infusion in 15 minutes. In Arm II: 3% NACL (with dose of 5 ml / kg) will be given to patientsas an intravenous infusion in 15 minutes. Patients were examined during treatment and 30 minutes after anti-edema treatment. Surgery will not commence until 30 minutes after anti-edema treatment. Patients' intracranial preasure, mean arterial preasure and state entropy values will be measured and recorded before treatment and every 1 minute until examination finished. An arterial blood gas will taken before treatment and every 10 minute until examination finished.( totaly 45 minute).
Sponsors
achmet ali
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients who between 18-65 years old,who belonged to American society of anesthesiologist classification (ASA) I- III and who would have elective supratentorial tumour surgery will be included. Other Inclusion criterias are: 1- Patients who didn't have a cranial surgery before. 2- Accepting to attend the research. 3- Patients who are found suitable for intraoperative intracranial pressure monitorization by the surgical team. 4- Patients who were guessed to have a high ICP (having a papilledema or/and having a shift at CT or/and increased ventricle volume).
Exclusion criteria
1- Patients who have a severe systemic disease( ASA greater than or equal to 4) 2- Patients who have hyponatremia or hypernatremia. 3- Patients who had anti-edematous therapy within 24 hours (mannitol or hypertonic saline) 4- Being allergic to mannitol, hypertonic saline, propofol, rokuronyum, fentanyl, remifentanyl , midazolam . 5- Patient who are morbid obese ( BMI > 40 )
Outcome results
None listed