Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery

NCT01926561 | Completed

• 1 other identifier: CR-11-072
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Syncope, Vasovagal

Keywords

Hypotensive bradycardic event; Interscalene brachial plexus block; Sitting position; Shoulder arthroscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  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

  after the sitting position (expected average of 2 hours including surgery readiness time and duration of surgery)

Study Arms (1)

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

Interventions

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.

Hypotensive bradycardic event

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 705-718, South Korea

Location

Related Publications (4)

• 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.

  PMID: 23741566 BACKGROUND

• 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.

  PMID: 22474545 BACKGROUND

• 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.

  PMID: 12873958 BACKGROUND

• 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.

  PMID: 9842820 BACKGROUND

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

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

Study Officials

• WoonSeok Roh, Doctor

  Daegu Catholic University Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 21, 2013
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

KR (1)