Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery

NCT ID: NCT01926561

Last Updated: 2013-10-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-06-30

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.

Conditions

Syncope, Vasovagal

Keywords

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Interscalene brachial plexus block

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daegu Catholic University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

JongHae Kim

Department of Anesthesiology and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

WoonSeok Roh, Doctor

Role: STUDY_CHAIR

Daegu Catholic University Medical Center

Locations

Daegu Catholic University Medical Center

Daegu, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 23741566 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22474545 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12873958 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9842820 (View on PubMed)

Other Identifiers

CR-11-072

Identifier Type: -

Identifier Source: org_study_id