Esketamine vs. Ketorolac for Prevention of Postoperative Pain and Cognitive Dysfunction After Total Knee Arthroplasty
8. april 2022 opdateret af: 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
Studieoversigt
Status
Rekruttering
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
160
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tianjin, Kina, 300052
- Rekruttering
- Tianjin Medical University General Hospital
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Kontakt:
- Guolin Wang
- Telefonnummer: +8618604755166
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år til 85 år (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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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Efter induktion af anæstesi injiceres normalt saltvand intravenøst i et volumen på 2 ml, og derefter en kontinuerlig infusion af 20 ml/t normalt saltvand indtil start af hudsutur.
Andre navne:
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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 navne:
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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 navne:
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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 navne:
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 navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tidspunkt for første postoperative smertestillende behov
Tidsramme: 1 time efter operationen
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Første postoperative smerte (NRS≥5) kontrolleres initialt ved titrering af sufentanyl.
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1 time efter operationen
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Samlet dosis af første postoperative smertestillende behov
Tidsramme: 1 time efter operationen
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Første postoperative smerte (NRS≥5) kontrolleres initialt ved titrering af sufentanyl.
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1 time efter operationen
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Guolin Wang, Tianjin Medical University General Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. november 2021
Primær færdiggørelse (Forventet)
15. juli 2022
Studieafslutning (Forventet)
30. juli 2022
Datoer for studieregistrering
Først indsendt
28. oktober 2021
Først indsendt, der opfyldte QC-kriterier
12. november 2021
Først opslået (Faktiske)
24. november 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske processer
- Postoperative komplikationer
- Smerte
- Neurologiske manifestationer
- Neurokognitive lidelser
- Kognitionsforstyrrelser
- Smerter, postoperativ
- Kognitiv dysfunktion
- Postoperative kognitive komplikationer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Psykotropiske stoffer
- Antidepressive midler
- Ketorolac
- Esketamin
- Ketorolac Tromethamin
Andre undersøgelses-id-numre
- GWang020
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