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

Primary Purpose

Infratentorial Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SctO2
BIS
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infratentorial Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of infratentoril neoplasms

Exclusion Criteria: Stroke

  • Diabetes mellitus
  • Chronic obstructive pulmonary disease
  • Anemia

Sites / Locations

  • Ozlem Korkmaz Dilmen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

The sitting

The prone

Arm Description

The sitting position Device sCtO2 Device BIS

The prone position Device sCtO2 Device BIS

Outcomes

Primary Outcome Measures

Cerebral oxygen saturation
After anesthesia induction cerebral oxygen saturation will record in each 3 minutes until the beginning of surgery

Secondary Outcome Measures

Full Information

First Posted
October 10, 2016
Last Updated
October 13, 2016
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT02933749
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infratentorial Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The sitting
Arm Type
Active Comparator
Arm Description
The sitting position Device sCtO2 Device BIS
Arm Title
The prone
Arm Type
Active Comparator
Arm Description
The prone position Device sCtO2 Device BIS
Intervention Type
Device
Intervention Name(s)
SctO2
Other Intervention Name(s)
INVOS-Covidien
Intervention Description
The non invasive cerebral oxymetry (INVOS-Covidien) has been used to measure cerebral oxygen saturation.
Intervention Type
Device
Intervention Name(s)
BIS
Intervention Description
Bispectral index
Primary Outcome Measure Information:
Title
Cerebral oxygen saturation
Description
After anesthesia induction cerebral oxygen saturation will record in each 3 minutes until the beginning of surgery
Time Frame
Change from baseline cerebral oxygen saturation up to skin incision

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of infratentoril neoplasms Exclusion Criteria: Stroke Diabetes mellitus Chronic obstructive pulmonary disease Anemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ozlem Korkmaz Dilmen
Phone
+902124143435
Email
korkmazdilmen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yusuf Tunali
Phone
+902124143000
Email
ytunali@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozlem Korkmaz Dilmen
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Ozlem Korkmaz Dilmen
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
22194128
Citation
Dilmen OK, Akcil EF, Tureci E, Tunali Y, Bahar M, Tanriverdi T, Aydin S, Yentur E. Neurosurgery in the sitting position: retrospective analysis of 692 adult and pediatric cases. Turk Neurosurg. 2011;21(4):634-40.
Results Reference
background
PubMed Identifier
16171668
Citation
Pohl A, Cullen DJ. Cerebral ischemia during shoulder surgery in the upright position: a case series. J Clin Anesth. 2005 Sep;17(6):463-9. doi: 10.1016/j.jclinane.2004.09.012.
Results Reference
background
PubMed Identifier
20508134
Citation
Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27.
Results Reference
background

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

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