Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery

• ClinicalTrials.gov Identifier: NCT01926561
• Recruitment Status: Completed
• First Posted: August 21, 2013
• Last Update Posted: October 8, 2013
• Sponsor: Daegu Catholic University Medical Center
• Information provided by (Responsible Party): JongHae Kim, Daegu Catholic University Medical Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Syncope, Vasovagal	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 Design

• Study Type: Observational
• Actual Enrollment: 68 participants
• 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
• Study Start Date: August 2011
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

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):583-8, table of contents.

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.

• Responsible Party: JongHae Kim, Department of Anesthesiology and Pain Medicine, Daegu Catholic University Medical Center
• ClinicalTrials.gov Identifier: NCT01926561
• Other Study ID Numbers: CR-11-072
• First Posted: August 21, 2013
• Last Update Posted: October 8, 2013
• Last Verified: October 2013

Keywords provided by JongHae Kim, 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; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases