Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Syncope, Vasovagal
• Intervention / Treatment: Other: Interscalene brachial plexus block

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.

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 705-718
    • Daegu Catholic University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability	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	Prior to ISBPB

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	20 minutes after the end of local anethetics injection
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	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	after the sitting position (expected average of 2 hours including surgery readiness time and duration of surgery)

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center
• Investigators: Study Chair: WoonSeok Roh, Doctor, Daegu Catholic University Medical Center

Publications and helpful links

General Publications

• Simeoforidou M, Vretzakis G, Chantzi E, Bareka M, Tsiaka K, Iatrou C, Karachalios T. Effect of interscalene brachial plexus block on heart rate variability. Korean J Anesthesiol. 2013 May;64(5):432-8. doi: 10.4097/kjae.2013.64.5.432. Epub 2013 May 24.
• Song SY, Roh WS. Hypotensive bradycardic events during shoulder arthroscopic surgery under interscalene brachial plexus blocks. Korean J Anesthesiol. 2012 Mar;62(3):209-19. doi: 10.4097/kjae.2012.62.3.209. Epub 2012 Mar 21.
• Sia S, Sarro F, Lepri A, Bartoli M. The effect of exogenous epinephrine on the incidence of hypotensive/bradycardic events during shoulder surgery in the sitting position during interscalene block. Anesth Analg. 2003 Aug;97(2):583-588. doi: 10.1213/01.ANE.0000070232.06352.48.
• Liguori GA, Kahn RL, Gordon J, Gordon MA, Urban MK. The use of metoprolol and glycopyrrolate to prevent hypotensive/bradycardic events during shoulder arthroscopy in the sitting position under interscalene block. Anesth Analg. 1998 Dec;87(6):1320-5. doi: 10.1097/00000539-199812000-00020.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 18, 2013
• First Posted (ESTIMATE): August 21, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 8, 2013
• Last Update Submitted That Met QC Criteria: October 7, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Sitting position; Interscalene brachial plexus block; Hypotensive bradycardic event; Shoulder arthroscopic surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: CR-11-072