Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JongHae Kim, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier:
NCT01926561
First received: August 14, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

Patients's demographics and perioperative factors affect the occurrence of hypotensive bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting position under interscalene block.


Condition Intervention
Syncope, Vasovagal
Other: Interscalene brachial plexus block

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Predicting the Occurence of Hypotensive Bradycardic Events in the Patients Undergoing Arthroscopic Shoulder Surgery in the Sitting Position Under Interscalene Brachial Plexus Block

Resource links provided by NLM:


Further study details as provided by Daegu Catholic University Medical Center:

Primary Outcome Measures:
  • Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability [ Time Frame: Prior to ISBPB ] [ Designated as safety issue: No ]
    Patients'age and gender, preoperative fasting time and volume of fluid administered, pre-block mean arterial pressure and heart rate, logarithmically transformed low frequency, high frequency, and total power of heart rate variability


Secondary Outcome Measures:
  • Side of the block, volume of local anesthetics used, number of patients having Horner's syndrome, hoarseness, and subjective dyspnea, degree of dermatomal and motor blockade [ Time Frame: 20 minutes after the end of local anethetics injection ] [ Designated as safety issue: No ]
    Side of the block, volume of local anesthetics used, number of patients having Horner's syndrome (ptosis, miosis, and anhidrosis), hoarseness, and subjective dyspnea, degree of dermatomal blockade (C5, C6, C7, C8, and T1), and degree of motor blockade (median, ulnar, radial, and musculocutaneous nerve)

  • Waiting time for sitting position, heart rate variability, mean arterial pressure, heart rate, frequency of antihypertensives and opioids use, and onset of hypotensive bradycardic events [ Time Frame: after the sitting position (expected average of 2 hours including surgery readiness time and duration of surgery) ] [ Designated as safety issue: No ]
    Waiting time for sitting position (time from the end of interscalene brachial plexus block to the sitting position), logarithmically transformed high frequency, low frequency, and total power of heart rate variability, mean arterial pressure, heart rate, frequency of intraoperative use of antihypertensives and opioids, and onset of hypotensive bradycardic events


Enrollment: 68
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hypotensive bradycardic event
The participants are assigned to hypotensive bradycardic event (HBE) group when they experience signs or symptoms associated with syncope, hypotension, or bradycardia, which are treated with vasopressors or inotropics following sitting position after interscalene brachial plexus block is done. Otherwise, they are assigned to non-HBE group.
Other: Interscalene brachial plexus block
After sterile draping around interscalene groove with povidone, a nerve stimulating needle connected to a nerve stimulator is inserted through the interscalene groove. Following involuntary contraction of shoulder, arm, forearm, or hand muscles with 0.5 milliamperes at 1 Hz using the nerve stimulator, 30 to 40 ml of mixture of 1% mepivacaine 20 ml and 0.75% ropivacaine 20 ml are injected.

Detailed Description:

Patients' age, Side of the block,Horner's syndrome, the degree of blockade, preoperative fasting time and fluid administration volume, waiting time for sitting position after the block, intraoperative use of opioids and antihypertensives, and change of heart rate variability before the block and after sitting position affect the occurrence of hypotensive bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting position under interscalene block.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients who are scheduled to receive elective shoulder arthroscopic surgery in the sitting position under interscalene brachial plexus block

Criteria

Inclusion Criteria:

  • Age between 15 and 80 years
  • American Society of Anesthesiologists physical status I-II
  • Body mass index < 35 kg/m2

Exclusion Criteria:

  • Coagulation deficiencies
  • Known allergies to local anesthetics
  • Neurologic deficit on the side to be operated
  • Inflammation at the puncture site for interscalene brachial plexus block
  • Coronary artery disease
  • Cardiac conduction disorders and arrhythmias
  • Congestive heart disease
  • Diabetes mellitus
  • Serum electrolyte abnormalities
  • Autonomic dysfunction
  • Psychiatric disorders
  • Patients refusal
  • Communications difficulties
  • Failure of interscalene brachial plexus block
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01926561

Locations
Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of, 705-718
Sponsors and Collaborators
Daegu Catholic University Medical Center
Investigators
Study Chair: WoonSeok Roh, Doctor Daegu Catholic University Medical Center
  More Information

Publications:
Responsible Party: JongHae Kim, Department of Anesthesiology and Pain Medicine, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT01926561     History of Changes
Other Study ID Numbers: CR-11-072
Study First Received: August 14, 2013
Last Updated: October 7, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Daegu Catholic University Medical Center:
Hypotensive bradycardic event
Interscalene brachial plexus block
Sitting position
Shoulder arthroscopic surgery

Additional relevant MeSH terms:
Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014