NCT02605005

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

1.1 years

First QC Date

November 6, 2015

Last Update Submit

November 11, 2015

Conditions

Keywords

interscalene block, general anesthesia, shoulder arthroscopy, cerebral oxygen saturation, beach chair position

Outcome Measures

Primary Outcomes (1)

  • changes in arterial pressure from baseline

    baseline, during the operation, one hour after the operation

Secondary Outcomes (1)

  • changes in regional cerebral oxygen saturation from baseline

    baseline, during the operation, one hour after the operation

Study Arms (2)

GA

general anesthesia

ISB

interscalene block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients for elective arthroscopy of the shoulder

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypoxia, Brain

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 16, 2015

Study Start

December 1, 2013

Primary Completion

January 1, 2015

Last Updated

November 16, 2015

Record last verified: 2015-11