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

Sponsor
Istanbul University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02933749
Collaborator
(none)
62
1
2
23
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SctO2
  • Device: BIS
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2016
Anticipated Primary Completion Date :
Oct 1, 2018
Anticipated Study Completion Date :
Oct 1, 2018

Arms and Interventions

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 Names:
  • 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 Names:
  • INVOS-Covidien
  • Device: BIS
    Bispectral index

    Outcome Measures

    Primary Outcome Measures

    1. Cerebral oxygen saturation [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Diagnosis of infratentoril neoplasms

    Exclusion Criteria: Stroke

    • Diabetes mellitus

    • Chronic obstructive pulmonary disease

    • Anemia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ozlem Korkmaz Dilmen Istanbul Turkey 34098

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Study Director: Ozlem Korkmaz Dilmen, Istanbul University Cerrahpasa School of Medicine, Istanbul, Turkey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Özlem Korkmaz Dilmen, MD, DESA, Associate Prof in Anesthesiology, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT02933749
    Other Study ID Numbers:
    • Istanbul
    First Posted:
    Oct 14, 2016
    Last Update Posted:
    Oct 14, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2016