- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03131258
The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy
Kidney transplant is the most effective choice of treatment for patients with end-stage kidney failure in terms of quality of life and longevity. Today, 20-25% of kidney transplantations are implemented with living donors.
Donor nephrectomy is an operations which has the end goal of a living donor donating one of his kidneys to a patient with end-stage kidney failure (1).
Pre-operative anxiety is a condition which is characterized by a random illness, being hospitalised, anesthesia, surgery, or uneasiness or anxiety stemming from not knowing what is to be experienced. Educating and informing in the pre-operative period is the first step in mentally preparing the patient for the operation. In some studies, it has been pointed out that patients who were thoroughly informed in the pre-operative period have lower anxiety levels both in the pre-operative and post-operative periods with also less levels of pain and increased recovery rates in the latter (2).
Anesthetic recovery starts at the end of the surgical process and ends with the anesthetized patient completely regaining a wide-awake, responsive state, defensive reflex, and muscle strength.
Post-operative pain is acute pain which starts with surgical trauma and ends with tissue healing (3). Providing optimal post-operative analgesia plays an important role in the prevention of post-operative complications (1,4,5).
There are studies which examine the link between pre-operative anxiety and post-operative pain (59,74,74,77,78). Patients who will undergo a donor nephrectomy constitute a specific group of patients both because they are not operated due to a health problem that they have and because the operation results with them losing an organ. There are no prospective studies about the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in individuals who have undergone donor nephrectomy in literature. Because of this, we have aimed to research prospectively the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in patients that were to undergo donor nephrectomy surgery.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- ASA I-II between 18-60 years
- Donor Nephrectomy patients
Exclusion Criteria:
- psychiatric disturbance
- medicinal allergy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Donor Nephrectomy
|
48 Donor Nephrectomy Patients
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Pain Intensity
Tidsramme: 48 hours
|
Patient's pain intensity as measured by visual analogue scale
|
48 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Erbil Türksal, MD, Ege University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
- 14-5.1/5
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Donor Nephrectomy
-
Haukeland University HospitalUniversity of BergenAktiv, ikke rekrutterendeIrritabelt tarmsyndromNorge
-
Mansoura UniversityAfsluttetNyretransplantation donor af venstre nyre
-
Weill Medical College of Cornell UniversityAfsluttetNyretransplantation | Nefrektomi | Levende donorer | Kirurgi, laparoskopiskForenede Stater
-
Erasmus Medical CenterIkke rekrutterer endnu
-
Ottawa Hospital Research InstituteCanadian Institutes of Health Research (CIHR); Canadian Blood ServicesAktiv, ikke rekrutterendeTransfusion af røde blodlegemerCanada
-
Aalborg University HospitalAfsluttet
-
National and Kapodistrian University of AthensRekruttering
-
Johns Hopkins UniversityWashington University School of Medicine; Yale University; Rush University... og andre samarbejdspartnereRekrutteringSlutstadie leversygdom | Slutstadie nyresygdomForenede Stater
-
Roswell Park Cancer InstituteAfsluttetLymfom | Myelodysplastiske syndromer | Leukæmi | Myelom og plasmacelle-neoplasmaForenede Stater
-
Nanfang Hospital of Southern Medical UniversityPeking University People's Hospital; Guangzhou First People's Hospital; Sun... og andre samarbejdspartnereAfsluttetHæmatopoietisk stamcelletransplantation | Minimal resterende sygdom | Tilbagefald | Donor lymfocytinfusionKina