Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery

Sponsor
Daegu Catholic University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01926561
Collaborator
(none)
68
1
10
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interscalene brachial plexus 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.

Study Design

Study Type:
Observational
Actual Enrollment :
68 participants
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
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability [Prior to ISBPB]

    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

Secondary Outcome Measures

  1. 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]

    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)

  2. 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)]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Daegu Catholic University Medical Center Daegu Korea, Republic of 705-718

Sponsors and Collaborators

  • Daegu Catholic University Medical Center

Investigators

  • Study Chair: WoonSeok Roh, Doctor, Daegu Catholic University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
JongHae Kim, Department of Anesthesiology and Pain Medicine, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier:
NCT01926561
Other Study ID Numbers:
  • CR-11-072
First Posted:
Aug 21, 2013
Last Update Posted:
Oct 8, 2013
Last Verified:
Oct 1, 2013
Keywords provided by JongHae Kim, Department of Anesthesiology and Pain Medicine, Daegu Catholic University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2013