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

NCT ID: NCT02933749

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-10-31

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.

Conditions

Infratentorial Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

The sitting

The sitting position Device sCtO2 Device BIS

Group Type: ACTIVE_COMPARATOR

SctO2

Intervention Type: DEVICE

The non invasive cerebral oxymetry (INVOS-Covidien) has been used to measure cerebral oxygen saturation.

BIS

Intervention Type: DEVICE

Bispectral index

The prone

The prone position Device sCtO2 Device BIS

Group Type: ACTIVE_COMPARATOR

SctO2

Intervention Type: DEVICE

The non invasive cerebral oxymetry (INVOS-Covidien) has been used to measure cerebral oxygen saturation.

BIS

Intervention Type: DEVICE

Bispectral index

Interventions

SctO2

The non invasive cerebral oxymetry (INVOS-Covidien) has been used to measure cerebral oxygen saturation.

Intervention Type: DEVICE

BIS

Bispectral index

Intervention Type: DEVICE

Other Intervention Names

INVOS-Covidien

Eligibility Criteria

Inclusion Criteria

• Diagnosis of infratentoril neoplasms

Exclusion Criteria

• Diabetes mellitus
• Chronic obstructive pulmonary disease
• Anemia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Özlem Korkmaz Dilmen

MD, DESA, Associate Prof in Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ozlem Korkmaz Dilmen

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Ozlem Korkmaz Dilmen

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ozlem Korkmaz Dilmen

Role: CONTACT

korkmazdilmen@gmail.com

+902124143435

Yusuf Tunali

Role: CONTACT

ytunali@yahoo.com

+902124143000

References

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.

Reference Type: BACKGROUND

PMID: 22194128 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16171668 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20508134 (View on PubMed)

Other Identifiers

Istanbul

Identifier Type: -

Identifier Source: org_study_id