Arthritis KneeNCT04814706
Gastric Volume in Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty
An observational study of Arthritis Knee, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In the past, some guidelines advised no oral intake for at least 8 hours before any surgery, However, research has shown risks associated with excessive fasting, such as postoperative insulin resistance, and advantages in shorter fasting protocols, such as reduced postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Arthritis Knee
- What is being tested?
- Carbohydrate drinking
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Mar 2021to 31 May 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
- Older adult
Study population: Study participants will be patients whom 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 to 85 years
- 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
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Ultrasound Assessment of Gastric Volume in Elderly Patients Undergoing Staged-bilateral Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Comparative Study
In the past, some guidelines advised no oral intake for at least 8 hours before any surgery, However, research has shown risks associated with excessive fasting, such as postoperative insulin resistance, and advantages in shorter fasting protocols, such as reduced postoperative nausea and vomiting.
The perioperative fasting guidelines of the European Society of Anaesthesiology focus on preoperative carbohydrates. They hold that it is safe for patients to drink carbohydrate-rich fluids up to 2 hours before elective surgery and that drinking carbohydrate-rich fluids improves subjective well-being, reduces thirst and hunger, and reduces postoperative insulin resistance at an evidence level of 1++. Nevertheless, data on drinking carbohydrate fluids before surgery in elderly patients are limited.
Read more
Some factors have been known to 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, the investigators will evaluate the effect of old age, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients 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.
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 operative, during the gastric volume measuring at preoperative holding area/ 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 posted24 Mar 2021
- Study start30 Mar 2021
- Primary completion31 May 2022
- Study completion31 May 2022
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
- 39 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
- NCT04814706
- Sponsor's protocol ID
- B-2103/673-302
- Status last verified
- Jul 2022
- First submitted
- 22 Mar 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Ultrasound Assessment of Gastric Volume in Elderly Patients Undergoing Staged-bilateral Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Comparative Study
- ClinicalTrials.gov ID
- NCT04814706
- Acronym / sponsor ID
- B-2103/673-302
- Conditions
- Arthritis Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 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.
In the past, some guidelines advised no oral intake for at least 8 hours before any surgery, However, research has shown risks associated with excessive fasting, such as postoperative insulin resistance, and advantages in shorter fasting protocols, such as reduced postoperative nausea and vomiting.
The perioperative fasting guidelines of the European Society of Anaesthesiology focus on preoperative carbohydrates. They hold that it is safe for patients to drink carbohydrate-rich fluids up to 2 hours before elective surgery and that drinking carbohydrate-rich fluids improves subjective well-being, reduces thirst and hunger, and reduces postoperative insulin resistance at an evidence level of 1++. Nevertheless, data on drinking carbohydrate fluids before surgery in elderly patients are limited.
Some factors have been known to 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, the investigators will evaluate the effect of old age, 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
- 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 to 85 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Study participants will be patients whom 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 to 85 years
- 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
Gastric volume 1
Time frame: First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Gastric volume measured before induction of spinal anesthesia using ultrasound
Gastric volume 2
Time frame: Second stage operative, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Gastric volume measured before induction of spinal anesthesia using ultrasound
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 Jul 2022.
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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 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: finished, 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?
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?
Gastric volume 1 (time frame: First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 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.