- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01687894
Vasopressin to Prevent Hypotension During Beach Chair Surgery
February 23, 2017 updated by: Kyung Yeon Yoo, Chonnam National University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
74
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gwangju, Korea, Republic of, 501-757
- Department of anesthesiology and pain medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing shoulder surgery in the beach chair position under the general anesthesia
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Vasopressins & propofol
Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.
|
Vasopressins propofol vasopressins sevoflurane
Other Names:
vasopressin propofol & placebo propofol
Other Names:
|
Placebo & propofol
Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia
|
vasopressin propofol & placebo propofol
Other Names:
Placebo propofol & placebo sevoflurane
Other Names:
|
Vasopressins & sevoflurane
Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia
|
Vasopressins propofol vasopressins sevoflurane
Other Names:
vasopressins sevoflurane placebo sevoflurane
Other Names:
|
Placebo & sevoflurane
Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia
|
Placebo propofol & placebo sevoflurane
Other Names:
vasopressins sevoflurane placebo sevoflurane
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline (before positioning) and lowest value within 10 min into beach chair position
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Jugular venous oxygen desaturation
Time Frame: Up to 30 min after the positioning
|
Jugular venous oxygen saturation is continuously measured whether its saturation is decreased below 50% or/and 40% for longer than 5 min.
|
Up to 30 min after the positioning
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral oxygen desaturation
Time Frame: Up to 30 min after the position change
|
Continuously observe near-infrared spectroscopy measured cerebral oxygenation before and after beach chair position whether oxygen saturation decrease more than 20% from pre-sitting values
|
Up to 30 min after the position change
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kyung Y Yoo, M.D.,Ph.D, Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 8, 2012
First Submitted That Met QC Criteria
September 15, 2012
First Posted (Estimate)
September 19, 2012
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 23, 2017
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Crystal Arthropathies
- Chondrocalcinosis
- Rotator Cuff Injuries
- Hypotension
- Rotator Cuff Tear Arthropathy
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Platelet Aggregation Inhibitors
- Natriuretic Agents
- Hypnotics and Sedatives
- Hemostatics
- Coagulants
- Anesthetics, Inhalation
- Vasoconstrictor Agents
- Antidiuretic Agents
- Anesthetics
- Propofol
- Sevoflurane
- Vasopressins
- Arginine Vasopressin
- Anesthetics, General
- Anesthetics, Intravenous
Other Study ID Numbers
- CNUH-2012-074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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