Clinical trial NCT01926561: Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope, Vasovagal
Keywords: Hypotensive bradycardic event
Interscalene brachial plexus block
Sitting position
Shoulder arthroscopic surgery
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 68
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability
timeFrame: Prior to ISBPB
Secondary outcomes:
measure: 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
timeFrame: 20 minutes after the end of local anethetics injection
measure: 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
timeFrame: after the sitting position (expected average of 2 hours including surgery readiness time and duration of surgery)
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: WoonSeok Roh, Doctor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.