- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05406245
The Effect of Stress on the Residual Gastric Volume
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Hyun-Jung Shin, MD., PhD.
- Telefonnummer: 82317877508
- E-mail: hjshin.anesth@gmail.com
Studiesteder
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republikken, 13620
- Rekruttering
- Seoul National University Bundang Hospital
-
Kontakt:
- Hyun-Jung Shin, MD., PhD.
- E-mail: hjshin.anesth@gmail.com
-
Ledende efterforsker:
- Hyo-Seok Na, MD., PhD.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous surgery of the upper gastrointestinal tract
- Achalasia
- Diabetes
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Gruppe C
Patienterne drak kulhydratvæske 2 timer før operationen.
|
Administration af kulhydratvæske
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of stress hormone 1
Tidsramme: 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
|
After induction of spinal anesthesia at first stage total knee arthroplasty/ an average 10 minutes
|
|
Level of stress hormone 2
Tidsramme: 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
|
After induction of spinal anesthesia at second stage total knee arthroplasty/ an average 10 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mavevolumen 1
Tidsramme: Første trins operation, under måling af mavevolumen ved præoperativt opholdsområde/ i gennemsnit 30 minutter
|
Mavevolumen målt før induktion af spinal anæstesi ved hjælp af ultralyd
|
Første trins operation, under måling af mavevolumen ved præoperativt opholdsområde/ i gennemsnit 30 minutter
|
|
Gastric volume 2
Tidsramme: Second 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
|
Second stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
|
|
Anxiety scale 1
Tidsramme: First stage operation, one day before surgery/ an average of 30 minutes
|
Anxiety scale measured before surgery
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First stage operation, one day before surgery/ an average of 30 minutes
|
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Anxiety scale 2
Tidsramme: Second stage operation, one day before surgery/ an average of 30 minutes
|
Anxiety scale measured before surgery
|
Second stage operation, one day before surgery/ an average of 30 minutes
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B-2206-761-301
Plan for individuelle deltagerdata (IPD)
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