Syncope, VasovagalNCT01926561
Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery
An observational study of Syncope, Vasovagal, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Syncope, Vasovagal
- What is being tested?
- Interscalene brachial plexus block
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who are scheduled to receive elective shoulder arthroscopic surgery in the sitting position under interscalene brachial plexus block
Who may be able to join
- Age between 15 and 80 years
- American Society of Anesthesiologists physical status I-II
- Body mass index < 35 kg/m2
Who cannot join
- 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
Show all 14Show fewer
- Congestive heart disease
- Diabetes mellitus
- Serum electrolyte abnormalities
- Autonomic dysfunction
- Psychiatric disorders
- Patients refusal
- Communications difficulties
- Failure of interscalene brachial plexus block
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Interscalene brachial plexus block
- Keywords
- Hypotensive bradycardic event, Interscalene brachial plexus block, Sitting position, Shoulder arthroscopic surgery
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interscalene brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability
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
Measured: Prior to ISBPB
Secondary outcomes (2)
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
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)
Measured: 20 minutes after the end of local anethetics injection
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
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
Measured: after the sitting position (expected average of 2 hours including surgery readiness time and duration of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Syncope, VasovagalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JongHae Kim, Daegu Catholic University Medical Center
- Investigators
- WoonSeok Roh, Doctor, Study chair, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926561
- Sponsor's protocol ID
- CR-11-072
- Status last verified
- Oct 2013
- First submitted
- 14 Aug 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23741566Song 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.
PubMed 22474545Sia 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.
PubMed 12873958Liguori 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.
PubMed 9842820
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01926561
- Acronym / sponsor ID
- CR-11-072
- Conditions
- Syncope, Vasovagal
- Keywords
- Hypotensive bradycardic event, Interscalene brachial plexus block, Sitting position, Shoulder arthroscopic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypotensive bradycardic event | – | Other: Interscalene brachial plexus blockThe 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. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are scheduled to receive elective shoulder arthroscopic surgery in the sitting position under interscalene brachial plexus block
Key inclusion criteria (3 listed)
- Age between 15 and 80 years
- American Society of Anesthesiologists physical status I-II
- Body mass index < 35 kg/m2
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene brachial plexus blockAfter 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. | Other | Hypotensive bradycardic event |
Primary outcome
Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability
Time frame: 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
2 secondary outcomes
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
- Background: PubMed 23741566Simeoforidou 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.
- Background: PubMed 22474545Song 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.
- Background: PubMed 12873958Sia 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.
- Background: PubMed 9842820Liguori 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WoonSeok Roh, Doctor study chair
Daegu Catholic University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope, Vasovagal, run by Daegu Catholic University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability (time frame: Prior to ISBPB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01926561, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2013.