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

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ClinicalTrials.gov Identifier: NCT02605005
Recruitment Status : Completed
First Posted : November 16, 2015
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
Osijek University Hospital

Brief 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.

Condition or disease
Impaired Oxygen Delivery Cerebral Hypoxia

Detailed 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.

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : December 2013
Actual Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort
GA
general anesthesia
ISB
interscalene block



Primary Outcome Measures :
  1. changes in arterial pressure from baseline [ Time Frame: baseline, during the operation, one hour after the operation ]

Secondary Outcome Measures :
  1. changes in regional cerebral oxygen saturation from baseline [ Time Frame: baseline, during the operation, one hour after the operation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients for elective arthroscopy of the shoulder
Criteria

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.

Responsible Party: Osijek University Hospital
ClinicalTrials.gov Identifier: NCT02605005     History of Changes
Other Study ID Numbers: 25-1:5484-3/2013.
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015

Keywords provided by Osijek University Hospital:
interscalene block, general anesthesia, shoulder arthroscopy, cerebral oxygen saturation, beach chair position

Additional relevant MeSH terms:
Hypoxia
Hypoxia, Brain
Signs and Symptoms, Respiratory
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs