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Spots Global Cancer Trial Database for Effects of the Prone and the Sitting Positions on the Brain Oxygenation in Posterior Fossa Surgery

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Trial Identification

Brief Title: Effects of the Prone and the Sitting Positions on the Brain Oxygenation in Posterior Fossa Surgery

Official Title: Effects of the Prone and the Sitting Positions on the Brain Oxygenation in Posterior Fossa Surgery

Study ID: NCT02933749

Interventions

SctO2
BIS

Study Description

Brief Summary: The sitting or prone positions are used for posterior fossa surgery. Although the sitting position may cause hemodynamic instability, venous air embolism, it also provides optimum access to midline lesions, decreases intracranial pressure. The sitting position has not been only used in neurosurgery, it has been also used in the shoulder surgery. The sitting position related hypotension may reduce the cerebral perfusion pressure, therefore may cause cerebral ischemia. The sitting position related cerebral ischemia has been shown in the shoulder surgery. The non invasive cerebral oxymetry (INVOS-Covidien) has been used to measure cerebral oxygen saturation. Some studies has been done to investigate whether the sitting position cause cerebral desaturation or not in the shoulder surgery by non invasive cerebral oxymetry. The study results are controversial. It has been investigated that the effect of the prone position on the cerebral oxygenation in the spine surgery and the investigators found that the prone position may increase cerebral oxygenation. However, all studies have been done in patients without intracranial pathology. We speculate that due to the sitting position reduces the intracranial pressure, it may improve the cerebral oxygenation in the patients have intracranial pathology. Therefore we will compare the sitting and the prone positions effects on the cerebral oxygenation in patients undergoing posterior fossa tumour surgery by non invasive cerebral oxymetry. Method: 62 patients have posterior fossa tumour will include the study. Patients will divide to 2 groups according to the surgical position, the prone (n=31) or the sitting (n=31). Patients heart rate, mean blood pressure (MAP), cerebral oxygen saturation (SctO2), peripheral oxygen saturation (SpO2), BIS values will record before the induction of anesthesia. Five minutes after the standard anesthesia induction all values will record and it will accept as a baseline. After that all these parameters will record in each 3 minutes until the beginning of surgery. Mean while, more than 5 % reduction in SctO2 and more than 20 % reduction in SctO2 and/or MAP will record. As well as, if the SctO2 reduces than 55 and 60 %, it will record.

Detailed Description: The sitting or prone positions are used for posterior fossa surgery. Although the sitting position may cause significant complications such as including hemodynamic instability, venous air embolism, paradoxical air embolism (PAE), pneumocephalus, peripheral neuropathy, quadriplegia and macroglossia, it also provides optimum access to midline lesions in posterior fossa and cervical spine, improves blood and cerebral spinal fluid drainage, decreases intracranial pressure, lowers airway pressure, and improves access to the endotracheal tube and ability to observe the face for signs of cranial nerves stimulations. The sitting position has not been only used in neurosurgery, it has been also used in the shoulder surgery. The sitting position related hypotension may reduce the cerebral perfusion pressure, therefore may cause cerebral ischemia. The sitting position related cerebral ischemia has been shown in the shoulder surgery. The non invasive cerebral oxymetry (INVOS-Covidien) has been used to measure cerebral oxygen saturation. Some studies has been done to investigate whether the sitting position cause cerebral desaturation or not in the shoulder surgery by non invasive cerebral oxymetry. The study results are controversial. It has been investigated that the effect of the prone position on the cerebral oxygenation in the spine surgery and the investigators found that the prone position may increase cerebral oxygenation. However, all studies have been done in patients without intracranial pathology. We speculate that due to the sitting position reduces the intracranial pressure, it may improve the cerebral oxygenation in the patients have intracranial pathology. Therefore we will compare the sitting and the prone positions effects on the cerebral oxygenation in patients undergoing posterior fossa tumour surgery by non invasive cerebral oxymetry. Method: 62 patients have posterior fossa tumour will include the study. Patients will divide to 2 groups according to the surgical position, the prone (n=31) or the sitting (n=31). Patients heart rate, mean blood pressure (MAP), cerebral oxygen saturation (SctO2), peripheral oxygen saturation (SpO2), BIS values will record before the induction of anesthesia. Five minutes after the standard anesthesia induction all values will record and it will accept as a baseline. After that all these parameters will record in each 3 minutes until the beginning of surgery. Mean while, more than 5 % reduction in SctO2 and more than 20 % reduction in SctO2 and/or MAP will record. As well as, if the SctO2 reduces than 55 and 60 %, it will record.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Ozlem Korkmaz Dilmen, Istanbul, , Turkey

Contact Details

Name: Ozlem Korkmaz Dilmen

Affiliation: Istanbul University - Cerrahpasa (IUC)

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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