Esketamine vs. Ketorolac for Prevention of Postoperative Pain and Cognitive Dysfunction After Total Knee Arthroplasty
8. april 2022 oppdatert av: Guolin Wang, Tianjin Medical University General Hospital
Esketamine vs. Ketorolac for Prevention of Postoperative Pain and Cognitive Dysfunction After Total Knee Arthroplasty in Patients: a Randomized Double-blind Controlled Trial
Purpose:
To compare esketamine and ketorolac separately and in combination to prevent postoperative pain and cognitive dysfunction after total knee arthroplasty
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
With the increase in human life span, orthopedic injuries and subsequent repair surgery have become a major health problem which impairs the life quality of patients and burdens healthcare systems worldwide.
Poor post-surgical pain control is a leading factor that hinders the physical rehabilitation and musculoskeletal functional recovery, and causes acute cognitive impairment and chronic pain syndrome.
Therefore, prophylaxis of postoperative pain is indispensable to postoperative comfort and satisfaction.
There is no denying the fact that pathologic pain is related to central glutaminergic system and N-methyl-d-aspartate (NMDA) receptor activation induced central sensitization.
Also, it is previously reported that neuroinflammation is associated with pain development and cognitive dysfunction.
Ketamine, a NMDA receptor antagonist, is effective in reversing NMDA receptor activation underlying pain states.
But the side effects of ketamine limit its clinical application, such as gibberish and agitation.
It is clarified that esketamine has lower side effects than ketamine and that antinociception of esketamine is stronger than ketamine.
The following study is carried out to evaluate whether esketamine and ketorolac can prevent postoperative pain and cognitive impairment after total knee arthroplasty in patients.
Studietype
Intervensjonell
Registrering (Forventet)
160
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Tianjin, Kina, 300052
- Rekruttering
- Tianjin Medical University General Hospital
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Ta kontakt med:
- Guolin Wang
- Telefonnummer: +8618604755166
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år til 85 år (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subject is scheduled to undergo total knee arthroplasty under a short general anesthesia of less than 2 hours
- Subject's American Society of Anesthesiologists physical status is I-II.
- The subject's parent/legally authorized guardian has given written informed consent to participate.
Exclusion Criteria:
- Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
- Subject has a diagnosis of Insulin dependent diabetes.
- Subject is allergy and contraindication to esketamine or ketorolac.
- Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids.
- Subject has any contraindication for the use of patient-controlled analgesia (PCA).
- Subject is pregnant or breast-feeding.
- Subject is obese (body mass index >30kg/m^2).
- Subject is incapacity to comprehend pain assessment and cognitive assessment.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Normal saline in patients
After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20 ml/h normal saline until starting skin suture.
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Etter induksjon av anestesi injiseres normalt saltvann intravenøst i et volum på 2ml, og deretter en kontinuerlig infusjon av 20ml/t normalt saltvann til start av hudsutur.
Andre navn:
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Aktiv komparator: Esketamine in patients
After the induction of anesthesia, esketamine is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h esketamine until starting skin suture.
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After the induction of anesthesia, esketamine is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h esketamine until starting skin suture.
Andre navn:
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Aktiv komparator: Ketorolac in patients
After the induction of anesthesia, ketorolac is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h ketorolac until starting skin suture.
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After the induction of anesthesia, Ketorolac is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h Ketorolac until starting skin suture.
Andre navn:
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Aktiv komparator: Esketamine and Ketorolac in patients
After the induction of anesthesia, 0.2mg/kg esketamine and 0.2mg/kg ketorolac are intravenously injected, and then a continuous infusion of 0.2mg/kg/h esketamine and 0.2mg/kg/h ketorolac until starting skin suture.
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After the induction of anesthesia, esketamine is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h esketamine until starting skin suture.
Andre navn:
After the induction of anesthesia, Ketorolac is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h Ketorolac until starting skin suture.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Cumulative opioid Consumption
Tidsramme: 72 hours after surgery
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Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing sufentanil in normal saline after leaving PACU (Postanesthesia care unit).
Sufentanyl cumulative consumption is recorded 72 hours postoperatively
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72 hours after surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Tidspunkt for første postoperative smertestillende behov
Tidsramme: 1 time etter operasjonen
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Første postoperative smerte (NRS≥5) kontrolleres initialt ved titrering av sufentanyl.
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1 time etter operasjonen
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Total dose av første postoperative smertestillende behov
Tidsramme: 1 time etter operasjonen
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Første postoperative smerte (NRS≥5) kontrolleres initialt ved titrering av sufentanyl.
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1 time etter operasjonen
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Pain Score (NRS) after movement
Tidsramme: 72 hours after surgery
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The pain score after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
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72 hours after surgery
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Mini-Mental State Examination (MMSE)
Tidsramme: 72 hours after surgery
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Cognitive performance was assessed with 0-30 points Mini-Mental State Examination (MMSE) scale.
Greater scores means better outcome.
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72 hours after surgery
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The incidence of Side Effects
Tidsramme: 72 hours after surgery
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The number of patients with post-operative side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus was recorded 72 hours after surgery.
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72 hours after surgery
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The levels of TNF-a in blood
Tidsramme: 72 hours after surgery
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Blood samples are collected to measure the levels of cytokine TNF-a using ELISA kits.
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72 hours after surgery
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The levels of chemokine CXCL1 in blood
Tidsramme: 72 hours after surgery
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Blood samples are collected to measure the levels of chemokine CXCL1 using ELISA kits.
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72 hours after surgery
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The levels of neuron specific enolase (NSE) in blood
Tidsramme: 72 hours after surgery
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Blood samples are collected to measure the levels of neuron specific enolase (NSE) using electrochemilumiscence kit.
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72 hours after surgery
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The levels of S-100 calcium-binding protein B in blood
Tidsramme: 72 hours after surgery
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Blood samples are collected to measure the levels of S-100 calcium-binding protein B using electrochemilumiscence kit.
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72 hours after surgery
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The levels of cortisol in blood
Tidsramme: 72 hours after surgery
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Blood samples are collected to measure the levels of cortisol using electrochemilumiscence kit.
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72 hours after surgery
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Pain Score (NRS) at rest
Tidsramme: 72 hours after surgery
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The pain score at rest was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
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72 hours after surgery
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The levels of chemokine CCL7 in blood
Tidsramme: 72 hours after surgery
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Blood samples are collected to measure the levels of chemokine CCL7 using ELISA kits.
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72 hours after surgery
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The levels of IL-18 in blood
Tidsramme: 72 hours after surgery
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Blood samples are collected to measure the levels of cytokine IL-18 using ELISA kits.
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72 hours after surgery
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The levels of IL-23 in blood
Tidsramme: 72 hours after surgery
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Blood samples are collected to measure the levels of cytokine IL-23 using ELISA kits.
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72 hours after surgery
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The levels of IL-17 in blood
Tidsramme: 72 hours after surgery
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Blood samples are collected to measure the levels of cytokine IL-17 using ELISA kits.
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72 hours after surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Guolin Wang, Tianjin Medical University General Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. november 2021
Primær fullføring (Forventet)
15. juli 2022
Studiet fullført (Forventet)
30. juli 2022
Datoer for studieregistrering
Først innsendt
28. oktober 2021
Først innsendt som oppfylte QC-kriteriene
12. november 2021
Først lagt ut (Faktiske)
24. november 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske prosesser
- Postoperative komplikasjoner
- Smerte
- Nevrologiske manifestasjoner
- Nevrokognitive lidelser
- Kognisjonsforstyrrelser
- Smerter, postoperativt
- Kognitiv dysfunksjon
- Postoperative kognitive komplikasjoner
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Syklooksygenase-hemmere
- Psykotropiske stoffer
- Antidepressive midler
- Ketorolac
- Esketamin
- Ketorolac trometamin
Andre studie-ID-numre
- GWang020
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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