Degenerative ArthritisNCT04815070
Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty
An observational study of Degenerative Arthritis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. Diabetic patients have a higher incidence of autonomic dysfunction, causing gastropathy. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Degenerative Arthritis
- What is being tested?
- Ultrasonic measurement of antral area
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2021to 7 Mar 2022
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Study participants will be patients whom are scheduled to undergo staged bilateral total knee arthroplasty requiring preoperative fasting period of at least 8 hours. 40 patients will be recruited in total. One cohort consisting 20 patients will be diabetic. The other cohort consisting of 20 patients will be non-diabetic.
Who may be able to join
- Patients scheduled for staged bilateral total knee arthroplasty aged 65 to 85 years
- American Society of Anestheiologist physical status classification 1, 2, and 3
- Body mass index < 35 kg/cm2
Who cannot join
- Previous surgery of the upper gastrointestinal tract
- Achalasia
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Comparison of Fasting Gastric Volume Using Ultrasound in Diabetic and Non-Diabetic Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty: A Prospective Observational Study
Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. Diabetic patients have a higher incidence of autonomic dysfunction, causing gastropathy. They are known to have gastroparesis and the consequent delayed gastric emptying which predisposes them to an increased risk of aspiration than the general population. Furthermore, other common factors can influence the gastric emptying rate, as for example, old age, pain, and the use of opioid analgesics.
In the previous study, evidence of increased pain was reported in patients undergoing staged bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) due to the surgical injury to the first operated knee.
In the present study, we will evaluate the effect of old age, diabetes, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing staged-bilateral total knee arthroplasty.
- Conditions
- Degenerative Arthritis
- Being tested
- Ultrasonic measurement of antral area
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic measurement of antral areaProcedure or surgery
Ultrasound exam is done before the induction of spinal anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed.
The cross-sectional area (CSA) of antrum is shown by the following formula: CSA = AP x CC x ㅠ/4.
Antral area will correspond to the average of the three measures.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic | A group of diabetic patients who have fasted for at least 8 hours undergoing staged bilateral total knee arthroplasty. Receives: Procedure: Ultrasonic measurement of antral area | |
| Non-Diabetic | A group of non-diabetic patients who have fasted for at least 8 hours undergoing staged bilateral total knee arthroplasty. Receives: Procedure: Ultrasonic measurement of antral area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Gastric Contents
A "full stomach" is defined as on containing a) solid or thick fluid content or b) 1.5 mL/kg of clear fluid.
Measured: Less than one hour prior to surgery
Secondary outcomes (2)
Numerical rating pain scale
Postoperative pain score (0 = no pain, 10 = very severe pain)
Measured: One hour prior to surgery, Postoperative 24 and 48 hour
Rescue analgesics
Amounts of the analgesics administered to manage the postoperative pain
Measured: Postoperative 24 and 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start29 Mar 2021
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ArthritisStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815070
- Sponsor's protocol ID
- B-2103/673-307
- Status last verified
- May 2022
- First submitted
- 22 Mar 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fasting Gastric Volume Using Ultrasound in Diabetic and Non-Diabetic Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04815070
- Acronym / sponsor ID
- B-2103/673-307
- Conditions
- Degenerative Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 24 Mar 2021 (actual)
- 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.
Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. Diabetic patients have a higher incidence of autonomic dysfunction, causing gastropathy. They are known to have gastroparesis and the consequent delayed gastric emptying which predisposes them to an increased risk of aspiration than the general population. Furthermore, other common factors can influence the gastric emptying rate, as for example, old age, pain, and the use of opioid analgesics.
In the previous study, evidence of increased pain was reported in patients undergoing staged bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) due to the surgical injury to the first operated knee.
In the present study, we will evaluate the effect of old age, diabetes, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing staged-bilateral total knee arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic | – | Procedure: Ultrasonic measurement of antral areaA group of diabetic patients who have fasted for at least 8 hours undergoing staged bilateral total knee arthroplasty. |
| Non-Diabetic | – | Procedure: Ultrasonic measurement of antral areaA group of non-diabetic patients who have fasted for at least 8 hours undergoing staged bilateral total knee arthroplasty. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Study participants will be patients whom are scheduled to undergo staged bilateral total knee arthroplasty requiring preoperative fasting period of at least 8 hours. 40 patients will be recruited in total. One cohort consisting 20 patients will be diabetic. The other cohort consisting of 20 patients will be non-diabetic.
Key inclusion criteria (3 listed)
- Patients scheduled for staged bilateral total knee arthroplasty aged 65 to 85 years
- American Society of Anestheiologist physical status classification 1, 2, and 3
- Body mass index < 35 kg/cm2
Key exclusion criteria (2 listed)
- Previous surgery of the upper gastrointestinal tract
- Achalasia
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 |
|---|---|---|
| Ultrasonic measurement of antral areaUltrasound exam is done before the induction of spinal anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed. The cross-sectional area (CSA) of antrum is shown by the following formula: CSA = AP x CC x ㅠ/4. Antral area will correspond to the average of the three measures. | Procedure or surgery | Diabetic, Non-Diabetic |
Primary outcome
Volume of Gastric Contents
Time frame: Less than one hour prior to surgery
A "full stomach" is defined as on containing a) solid or thick fluid content or b) 1.5 mL/kg of clear fluid.
2 secondary outcomes
Numerical rating pain scale
Time frame: One hour prior to surgery, Postoperative 24 and 48 hour
Rescue analgesics
Time frame: Postoperative 24 and 48 hour
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 5 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Degenerative Arthritis, run by Seoul National University Bundang 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?
The sponsor lists 3 inclusion and 2 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 5 May 2022. 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?
Volume of Gastric Contents (time frame: Less than one hour prior to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2022.