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

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ClinicalTrials.gov Identifier: NCT02933749
Recruitment Status : Unknown
Verified October 2016 by Özlem Korkmaz Dilmen, Istanbul University.
Recruitment status was:  Not yet recruiting
First Posted : October 14, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Özlem Korkmaz Dilmen, Istanbul University

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.


Condition or disease Intervention/treatment Phase
Infratentorial Neoplasms Device: SctO2 Device: BIS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effects of the Prone and the Sitting Positions on the Brain Oxygenation in Posterior Fossa Surgery
Study Start Date : November 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Active Comparator: The sitting
The sitting position Device sCtO2 Device BIS
Device: SctO2
The non invasive cerebral oxymetry (INVOS-Covidien) has been used to measure cerebral oxygen saturation.
Other Name: INVOS-Covidien

Device: BIS
Bispectral index

Active Comparator: The prone
The prone position Device sCtO2 Device BIS
Device: SctO2
The non invasive cerebral oxymetry (INVOS-Covidien) has been used to measure cerebral oxygen saturation.
Other Name: INVOS-Covidien

Device: BIS
Bispectral index




Primary Outcome Measures :
  1. Cerebral oxygen saturation [ Time Frame: Change from baseline cerebral oxygen saturation up to skin incision ]
    After anesthesia induction cerebral oxygen saturation will record in each 3 minutes until the beginning of surgery



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of infratentoril neoplasms

Exclusion Criteria: Stroke

  • Diabetes mellitus
  • Chronic obstructive pulmonary disease
  • Anemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933749


Contacts
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Contact: Ozlem Korkmaz Dilmen +902124143435 korkmazdilmen@gmail.com
Contact: Yusuf Tunali +902124143000 ytunali@yahoo.com

Locations
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Turkey
Ozlem Korkmaz Dilmen
Istanbul, Turkey, 34098
Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Ozlem Korkmaz Dilmen Istanbul University Cerrahpasa School of Medicine Istanbul Turkey

Publications:
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Responsible Party: Özlem Korkmaz Dilmen, MD, DESA, Associate Prof in Anesthesiology, Istanbul University
ClinicalTrials.gov Identifier: NCT02933749     History of Changes
Other Study ID Numbers: Istanbul
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Infratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases