Arthritis KneeNCT05406245
The Effect of Stress on the Residual Gastric Volume
An observational study of Arthritis Knee, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In our institution, many patients undergo staged bilateral total knee arthroplasty at weekly intervals, and most of the patients are older adults with degenerative arthritis. As recommended, the older adult patients who undergoing total knee arthroplasty drink carbohydrate-containing fluid (400 ml) 2 hours prior to… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Arthritis Knee
- What is being tested?
- Carbohydrate drinking
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2022to 15 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Study participants will be patients who are scheduled to undergo staged bilateral total knee arthroplasty requiring administration of carbohydrate-containing fluid 2 hours prior to surgery.
Who may be able to join
- Patients scheduled for staged bilateral total knee arthroplasty aged ≥ 65
- American Society of Anesthesiologists physical status classification 1, 2, and 3
- Body mass index < 35 kg/cm2
- Patients administered carbohydrate-containing fluid 2 hours prior to surgery
Who cannot join
- Previous surgery of the upper gastrointestinal tract
- Achalasia
- Diabetes
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Hyun-Jung Shin, MD., PhD., hjshin.anesth@gmail.com
Hyo-Seok Na, MD., PhD.
About this study
Official title: The Effect of Stress on the Residual Gastric Volume in Older Adults Undergoing Staged-bilateral Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Study
In our institution, many patients undergo staged bilateral total knee arthroplasty at weekly intervals, and most of the patients are older adults with degenerative arthritis. As recommended, the older adult patients who undergoing total knee arthroplasty drink carbohydrate-containing fluid (400 ml) 2 hours prior to surgery. In this type of surgery, there are additional points to consider when applying the fasting guidelines. This is because, in addition to the factor of advanced age, which can affect gastric emptying time, the patient's physical, medical, and psychological conditions at the first and the second operation may be different. For example, the effect of the acute pain that occurs after the first total knee arthroplasty and subsequent opioids administered on gastric motility cannot be ignored. However, to date, there have been no studies examining the association of stress (emotional and surgical) and residual gastric volume of older adult patients with staged bilateral total knee arthroplasty and whether there is a difference according to the stage when carbohydrate-containing fluid is ingested.
In the present study, the investigators will evaluate the effect of emotional stress, surgical stress, pain, and the use of opioids on the residual gastric volume in older adults undergoing staged-bilateral total knee arthroplasty.
- Conditions
- Arthritis Knee
- Being tested
- Carbohydrate drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate drinkingDietary supplement
Administration of carbohydrate fluid
| Study group | Role | What they receive |
|---|---|---|
| Group C | Patients drank carbohydrate fluid 2 hours prior to surgery. Receives: Dietary Supplement: Carbohydrate drinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of stress hormone 1
Stress hormone (interleukin-1β, interleukin-6, interleukin-10, and tumor necrosis factor-α) measured after induction of spinal anesthesia
Measured: After induction of spinal anesthesia at first stage total knee arthroplasty/ an average 10 minutes
Level of stress hormone 2
Stress hormone (interleukin-1β, interleukin-6, interleukin-10, and tumor necrosis factor-α) measured after induction of spinal anesthesia
Measured: After induction of spinal anesthesia at second stage total knee arthroplasty/ an average 10 minutes
Secondary outcomes (4)
Gastric volume 1
Gastric volume measured before induction of spinal anesthesia using ultrasound
Measured: First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Gastric volume 2
Gastric volume measured before induction of spinal anesthesia using ultrasound
Measured: Second stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Anxiety scale 1
Anxiety scale measured before surgery
Measured: First stage operation, one day before surgery/ an average of 30 minutes
Anxiety scale 2
Anxiety scale measured before surgery
Measured: Second stage operation, one day before surgery/ an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Jul 2022
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 53 participants (estimated)
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
- Investigators
- Hyo-Seok Na, MD., PhD., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406245
- Sponsor's protocol ID
- B-2206-761-301
- Status last verified
- Jul 2022
- First submitted
- 1 Jun 2022
- Last updated
- 5 Jul 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 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress on the Residual Gastric Volume in Older Adults Undergoing Staged-bilateral Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05406245
- Acronym / sponsor ID
- B-2206-761-301
- Conditions
- Arthritis Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 6 Jun 2022 (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.
In our institution, many patients undergo staged bilateral total knee arthroplasty at weekly intervals, and most of the patients are older adults with degenerative arthritis. As recommended, the older adult patients who undergoing total knee arthroplasty drink carbohydrate-containing fluid (400 ml) 2 hours prior to surgery. In this type of surgery, there are additional points to consider when applying the fasting guidelines. This is because, in addition to the factor of advanced age, which can affect gastric emptying time, the patient's physical, medical, and psychological conditions at the first and the second operation may be different. For example, the effect of the acute pain that occurs after the first total knee arthroplasty and subsequent opioids administered on gastric motility cannot be ignored. However, to date, there have been no studies examining the association of stress (emotional and surgical) and residual gastric volume of older adult patients with staged bilateral total knee arthroplasty and whether there is a difference according to the stage when carbohydrate-containing fluid is ingested.
In the present study, the investigators will evaluate the effect of emotional stress, surgical stress, pain, and the use of opioids on the residual gastric volume in older adults undergoing staged-bilateral total knee arthroplasty.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group C | – | Dietary Supplement: Carbohydrate drinkingPatients drank carbohydrate fluid 2 hours prior to surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Study participants will be patients who are scheduled to undergo staged bilateral total knee arthroplasty requiring administration of carbohydrate-containing fluid 2 hours prior to surgery.
Key inclusion criteria (4 listed)
- Patients scheduled for staged bilateral total knee arthroplasty aged ≥ 65
- American Society of Anesthesiologists physical status classification 1, 2, and 3
- Body mass index < 35 kg/cm2
- Patients administered carbohydrate-containing fluid 2 hours prior to surgery
Key exclusion criteria (3 listed)
- Previous surgery of the upper gastrointestinal tract
- Achalasia
- Diabetes
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 |
|---|---|---|
| Carbohydrate drinkingAdministration of carbohydrate fluid | Dietary supplement | Group C |
Primary outcome
Level of stress hormone 1
Time frame: After induction of spinal anesthesia at first stage total knee arthroplasty/ an average 10 minutes
Stress hormone (interleukin-1β, interleukin-6, interleukin-10, and tumor necrosis factor-α) measured after induction of spinal anesthesia
Level of stress hormone 2
Time frame: After induction of spinal anesthesia at second stage total knee arthroplasty/ an average 10 minutes
Stress hormone (interleukin-1β, interleukin-6, interleukin-10, and tumor necrosis factor-α) measured after induction of spinal anesthesia
4 secondary outcomes
Gastric volume 1
Time frame: First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Gastric volume 2
Time frame: Second stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Anxiety scale 1
Time frame: First stage operation, one day before surgery/ an average of 30 minutes
Anxiety scale 2
Time frame: Second stage operation, one day before surgery/ an average of 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 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.
Hyo-Seok Na, MD., PhD. principal investigator
Seoul National University Bundang 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 Arthritis Knee, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Jung Shin, MD., PhD. (82317877508, hjshin.anesth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of stress hormone 1 (time frame: After induction of spinal anesthesia at first stage total knee arthroplasty/ an average 10 minutes). The study lists 2 primary outcomes in all. 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 Jul 2022.