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.
|Study Design:||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|
- Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability [ Time Frame: Prior to ISBPB ] [ Designated as safety issue: No ]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
- 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 ] [ Designated as safety issue: No ]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)
- 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) ] [ Designated as safety issue: No ]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
|Study Start Date:||August 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01926561
|Korea, Republic of|
|Daegu Catholic University Medical Center|
|Daegu, Korea, Republic of, 705-718|
|Study Chair:||WoonSeok Roh, Doctor||Daegu Catholic University Medical Center|