Rotator Cuff Tear ArthropathyNCT01687894
Vasopressin to Prevent Hypotension During Beach Chair Surgery
An observational study of Rotator Cuff Tear Arthropathy, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia. The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are evaluated during surgery in BCP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Tear Arthropathy
- What is being tested?
- Vasopressins, propofol and sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Dec 2014
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing shoulder surgery in the beach chair position under the general anesthesia
Inclusion Criteria: elective arthroscopic shoulder surgery under general anesthesia in beach chair position
Exclusion Criteria: preexisting cerebrovascular diseases, history of orthostatic hypotension, age less than 18 yr, and the American Society of Anesthesiologists physical status IV or V
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine
Gwangju, 501-757
About this study
Official title: Clinical Trials of Vasopressin for Prevention of Hypotension During Shoulder Surgery in Beach Chair Position Under General Anesthesia
Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia. The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are evaluated during surgery in BCP.
Read the detailed description
Patients undergoing shoulder surgery in BCP under general anaesthesia are randomly allocated to receive i.v. normal saline (control group) or AVP 0.05 or 0.07 U kg-1 (AVP group, n = 15 each) 2 min before moving into BCP. Mean arterial pressure (MAP), heart rate (HR), jugular venous bulb oxygen saturation (SjvO2) and regional cerebral tissue oxygen saturation (SctO2) are measured before (pre-sitting in supine position) and after patients assumed BCP.
- Conditions
- Rotator Cuff Tear Arthropathy
- Being tested
- Vasopressins, Placebo, propofol, sevoflurane
- Keywords
- cerebral oxygen saturation, beach chair position, hemodynamic, jugular venous oximetry
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinsDrug
Also called Arginine vasopressin
Vasopressins propofol vasopressins sevoflurane
PlaceboDrug
Also called saline 10 ml as placebo
Placebo propofol \& placebo sevoflurane
propofolDrug
Also called Intravenous anesthetic
vasopressin propofol \& placebo propofol
sevofluraneDrug
Also called general anesthetic
vasopressins sevoflurane placebo sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Vasopressins & propofol | Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia. Receives: Drug: Vasopressins; Drug: propofol | |
| Placebo & propofol | Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia Receives: Drug: Placebo; Drug: propofol | |
| Vasopressins & sevoflurane | Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia Receives: Drug: Vasopressins; Drug: sevoflurane | |
| Placebo & sevoflurane | Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia Receives: Drug: Placebo; Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The magnitude of decrease of mean arterial pressure
Continuously measure mean arterial blood pressure before and after position change. Calculate the magnitude of maximum decrease of mean arterial pressure from baseline
Measured: Baseline (before positioning) and lowest value within 10 min into beach chair position
Secondary outcomes (1)
Jugular venous oxygen desaturation
Jugular venous oxygen saturation is continuously measured whether its saturation is decreased below 50% or/and 40% for longer than 5 min.
Measured: Up to 30 min after the positioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Tear ArthropathyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chonnam National University
- Responsible party
- Principal investigator, Kyung Yeon Yoo, Chonnam National University Hospital
- Investigators
- Kyung Y Yoo, M.D.,Ph.D, Principal investigator, Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687894
- Sponsor's protocol ID
- CNUH-2012-074
- Status last verified
- Sep 2012
- First submitted
- 8 Sep 2012
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jang EA, Song JA, Shin JY, Yoon JJ, Yoo KY, Jeong S. Background anaesthetic agents do not influence the impact of arginine vasopressin on haemodynamic states and cerebral oxygenation during shoulder surgery in the beach chair position: a prospective, single-blind study. BMC Anesthesiol. 2017 May 30;17(1):73. doi: 10.1186/s12871-017-0364-9.
PubMed 28558702
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials of Vasopressin for Prevention of Hypotension During Shoulder Surgery in Beach Chair Position Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01687894
- Acronym / sponsor ID
- CNUH-2012-074
- Conditions
- Rotator Cuff Tear Arthropathy
- Keywords
- cerebral oxygen saturation, beach chair position, hemodynamic, jugular venous oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Chonnam National University
- Study start
- May 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Sep 2012 (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 undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia. The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are evaluated during surgery in BCP.
Detailed description
Patients undergoing shoulder surgery in BCP under general anaesthesia are randomly allocated to receive i.v. normal saline (control group) or AVP 0.05 or 0.07 U kg-1 (AVP group, n = 15 each) 2 min before moving into BCP. Mean arterial pressure (MAP), heart rate (HR), jugular venous bulb oxygen saturation (SjvO2) and regional cerebral tissue oxygen saturation (SctO2) are measured before (pre-sitting in supine position) and after patients assumed BCP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vasopressins & propofol | – | Drug: Vasopressins, Drug: propofolAdminister vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia. |
| Placebo & propofol | – | Drug: Placebo, Drug: propofolAdminister saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia |
| Vasopressins & sevoflurane | – | Drug: Vasopressins, Drug: sevofluraneAdminister vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia |
| Placebo & sevoflurane | – | Drug: Placebo, Drug: sevofluranePlacebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing shoulder surgery in the beach chair position under the general anesthesia
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 |
|---|---|---|
| VasopressinsAlso: Arginine vasopressinVasopressins propofol vasopressins sevoflurane | Drug | Vasopressins & propofol, Vasopressins & sevoflurane |
| PlaceboAlso: saline 10 ml as placeboPlacebo propofol \& placebo sevoflurane | Drug | Placebo & propofol, Placebo & sevoflurane |
| propofolAlso: Intravenous anestheticvasopressin propofol \& placebo propofol | Drug | Placebo & propofol, Vasopressins & propofol |
| sevofluraneAlso: general anestheticvasopressins sevoflurane placebo sevoflurane | Drug | Placebo & sevoflurane, Vasopressins & sevoflurane |
Primary outcome
The magnitude of decrease of mean arterial pressure
Time frame: Baseline (before positioning) and lowest value within 10 min into beach chair position
Continuously measure mean arterial blood pressure before and after position change. Calculate the magnitude of maximum decrease of mean arterial pressure from baseline
1 secondary outcome
Jugular venous oxygen desaturation
Time frame: Up to 30 min after the positioning
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 27 Feb 2017.
- Derived from this study: PubMed 28558702Jang EA, Song JA, Shin JY, Yoon JJ, Yoo KY, Jeong S. Background anaesthetic agents do not influence the impact of arginine vasopressin on haemodynamic states and cerebral oxygenation during shoulder surgery in the beach chair position: a prospective, single-blind study. BMC Anesthesiol. 2017 May 30;17(1):73. doi: 10.1186/s12871-017-0364-9.
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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.
Kyung Y Yoo, M.D.,Ph.D principal investigator
Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital
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 Rotator Cuff Tear Arthropathy, run by Chonnam National University Hospital 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?
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 27 Feb 2017. 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?
The magnitude of decrease of mean arterial pressure (time frame: Baseline (before positioning) and lowest value within 10 min into beach chair position). 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 NCT01687894, which also lists 1 linked publication.
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 27 Feb 2017.