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Completed

NCT Number: NCT01926561

Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery

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.

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Key information

Conditions

Syncope, Vasovagal Autonomic Nervous System Diseases Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Syncope Unconsciousness

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Daegu Catholic University Medical Center

Daegu, 705-718, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interscalene brachial plexus block

Other

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.

Primary outcomes

  1. Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability

    Time frame: Prior to ISBPB

    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 outcomes

  1. 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

    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)

  2. 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)

    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

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

Predicting the Occurence of Hypotensive Bradycardic Events in the Patients Undergoing Arthroscopic Shoulder Surgery in the Sitting Position Under Interscalene Brachial Plexus Block

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 21, 2013
Registry last updated
Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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