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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01926561
Enrollment
68
Registered
2013-08-21
Start date
2011-08-31
Completion date
2012-06-30
Last updated
2013-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope, Vasovagal

Keywords

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

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.

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.

Interventions

OTHERInterscalene 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.

Sponsors

Daegu Catholic University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variabilityPrior to ISBPBPatients'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

MeasureTime frameDescription
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 blockade20 minutes after the end of local anethetics injectionSide 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 eventsafter 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026