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Effect of the Side of Interscalene Block on Bradycardia and Hypotension in Beach Chair Position

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Larissa University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Marina Simaioforidou, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01755780
First received: December 19, 2012
Last updated: July 9, 2014
Last verified: July 2014
  Purpose
The Left interscalene block has a different effect on heart's autonomic nervous system, compared to Right interscalene block. This effect is evident on the occurrence of bradycardia and hypotension during shoulder surgery in the beach chair position

Condition Intervention
Shoulder Surgery
Beach Chair Position
Interscalene Block
Hypotension
Bradycardia
Autonomic Nervous System
Other: Left interscalene block
Other: Right interscalene block

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of the Side of Interscalene Block on the Occurrence of Bradycardia and Hypotension During Shoulder Surgery in the Beach Chair Position

Resource links provided by NLM:


Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • Interscalene block and beach chair positioning [ Time Frame: Intraoperatively ] [ Designated as safety issue: No ]
    Effect of interscalene block on hypotension and bradycardia during beach chair positioning


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Left interscalene block
Left interscalene block on hypotension and bradycardia during beach chair positioning
Other: Left interscalene block
Right interscalene block
Right interscalene block on hypotension and bradycardia during beach chair positioning
Other: Right interscalene block

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients for elective shoulder surgery
Criteria

Inclusion Criteria:

  • elective shoulder surgery
  • Age 50- 80 years old
  • ASA II - IV

Exclusion Criteria:

  • Coagulopathy disorders
  • Infection at the puncture site for the interscalene block
  • Neurological deficit on the side to be operated
  • Allergy to local anesthetics
  • Psychiatric disorders
  • Patient's refusal
  • Problems with patient communication
  • Failure of the interscalene block
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755780

Locations
Greece
Larissa University Hospital
Larissa, Thessally, Greece, 41110
Sponsors and Collaborators
Larissa University Hospital
Investigators
Principal Investigator: Marina Simaioforidou, MD Larissa University Hospital
Study Director: George Vretzakis, Medicine Larissa University Hospital
Study Chair: Katerina Tsiaka, Medicine Larissa University Hospital
Study Chair: George Basdekis, Medicine Larissa University Hospital
Study Chair: Athanasios Drakos, Medicine Larissa University Hospital
  More Information

Responsible Party: Marina Simaioforidou, Anesthesiologist, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01755780     History of Changes
Other Study ID Numbers: Intrerscalene beach chair 
Study First Received: December 19, 2012
Last Updated: July 9, 2014
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Hypotension
Bradycardia
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on December 07, 2016