The Impact of a Beach Chair Position During Shoulder Arthroscopy on Regional Cerebral Oxygen Saturation : Comparison of Interscalene Block and General Anesthesia

Cerebral Hypoxia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605005
• Other study ID #: 25-1:5484-3/2013.
• Status: Completed
• Phase: N/A
• First received: November 6, 2015
• Last updated: November 11, 2015
• Start date: December 2013

Study information

• Verified date: November 2015
• Source: Osijek University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate the relationship between the patient positioning in the beach chair position with consequential arterial pressure changes and their influence on regional cerebral oxygen saturation under two anesthesia techniques, general anesthesia in one group of patients and interscalene block in the second group of patients.

Description:

The participants of the study are patients scheduled for elective shoulder athroscopy. The patients randomise themselves by choosing the type of anesthesia technique (general anesthesia or interscalene block) after detailed description of both techniques. They receive the standard, routine medical care (monitoring and anesthesia techniques) during which the obtained data of arterial pressure, heart rate, peripheral and cerebral oxygen saturation will be statistically analysed and compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Inclusion criterion for the study was the approval for surgery under general or regional anesthesia with ASA I and ASA II patients classification. -

Exclusion Criteria:

• The patients who have refused to take part in the study, patients assessed as ASA III or higher, who have cerebrovascular or coronary disease, coagulopathy, hypersensitivity to local anesthetics or other contraindications to one or the other type of anesthetic techniques All patients in whom the operation lasted less than 20 minutes or longer than 90 minutes, have been also excluded from the study.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hypoxia
• Hypoxia, Brain
• Impaired Oxygen Delivery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Osijek University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in arterial pressure from baseline		baseline, during the operation, one hour after the operation	No
Secondary	changes in regional cerebral oxygen saturation from baseline		baseline, during the operation, one hour after the operation	No