- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02021851
Prevention of Nausea and Vomiting in Patients After Surgery
THE EFFECT OF THE COMBINATION OF DEXAMETHASONE WITH ONDANSETRON VERSUS DEXAMETHASONE WITH APREPITANT TO PREVENT POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERY
Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The incidence can be as high as 80 percent in high-risk patients. Investigators designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic surgery.
Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years patients scheduled for laparoscopic surgery were included in this study. Anesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen / air mixture in all patients. Remifentanil was continuously infused during surgery. Patients were randomly divided into two groups. Patients in the dexamethasone and aprepitant group (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of anesthesia.
PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The blindly evaluated primary outcome was complete response. The secondary outcomes were incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Statistical analyses were performed using Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P<0.05 was considered statistically significant.Investigators hypothesized that the antiemetic efficacy of the aprepitant and dexamethasone combination is superior compared with ondansetron and dexamethasone combination following the laparoscopic surgery.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Kozyatagi ISTANBUL
-
Devlet Yolu, Ankara cad 102/104, Kozyatagi ISTANBUL, Tyrkia, 34752
- Yeditepe University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 18 Years to 60 Years
- ASA (American Society of Anesthesiologist) physical status I or II
- Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy
Exclusion Criteria:
- Hypersensitivity or contraindication to the study medications,
- Antiemetic drug or steroid use within 24 hours before anesthesia,
- History of diabetes mellitus,
- History of motion sickness or postoperative nausea and vomiting,
- Pregnancy,
- Breast feeding
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Group DA: Dexamethasone and aprepitant
Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral)
|
|
|
Placebo komparator: Group DO: Dexamethasone and ondansetron
Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Complete response
Tidsramme: One year
|
The primary outcome is complete response: A complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.
|
One year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Nausea
Tidsramme: One year
|
The secondary outcome measure is incidence of nausea
|
One year
|
|
Retching
Tidsramme: One year
|
The secondary outcome measure is incidence of retching
|
One year
|
|
Vomiting
Tidsramme: One year
|
The secondary outcome measure is incidence of vomiting
|
One year
|
|
Need of rescue antiemetic
Tidsramme: One year
|
The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery.
|
One year
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Opioid consumption
Tidsramme: One year
|
Opioid consumption
|
One year
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Postoperative komplikasjoner
- Tegn og symptomer, fordøyelseskanal
- Kvalme
- Oppkast
- Postoperativ kvalme og oppkast
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Proteasehemmere
- Dermatologiske midler
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninmidler
- Serotonin-antagonister
- Anti-angst midler
- Antipruritika
- Neurokinin-1-reseptorantagonister
- Deksametason
- Deksametasonacetat
- BB 1101
- Ondansetron
- Aprepitant
Andre studie-ID-numre
- 125 (Norgine)
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