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

NCT02933749 | Unknown

• 1 other identifier: Istanbul
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Infratentorial Neoplasms

Outcome Measures

Primary Outcomes (1)

• Cerebral oxygen saturation

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

  Change from baseline cerebral oxygen saturation up to skin incision

Study Arms (2)

The sitting

ACTIVE COMPARATOR

The sitting position Device sCtO2 Device BIS

Device: SctO2; Device: BIS

The prone

ACTIVE COMPARATOR

The prone position Device sCtO2 Device BIS

Device: SctO2; Device: BIS

Interventions

SctO2 DEVICE

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

Also known as: INVOS-Covidien

The prone; The sitting

BIS DEVICE

Bispectral index

The prone; The sitting

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of infratentoril neoplasms

You may not qualify if:

• Diabetes mellitus
• Chronic obstructive pulmonary disease
• Anemia

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Ozlem Korkmaz Dilmen

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 22194128 BACKGROUND

• 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.

  PMID: 16171668 BACKGROUND

• 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.

  PMID: 20508134 BACKGROUND

MeSH Terms

Conditions

Infratentorial Neoplasms

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ozlem Korkmaz Dilmen

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Ozlem Korkmaz Dilmen

CONTACT

+902124143435; korkmazdilmen@gmail.com

Yusuf Tunali

CONTACT

+902124143000; ytunali@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DESA, Associate Prof in Anesthesiology

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 14, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)