Effects of Propofol-dexmedetomidine on Immune Function in Patients With Cancer Larynx
Effects of Propofol-dexmedetomidine on Immune Function During Total Laryngectomy Surgery Compared With Isoflurane Anesthesia
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The perioperative period might be a critical time in primary cancer surgery because many factors can affect whether recurrence, or metastasis , or elimination by the immune system.
Cancer surgery can induce an acute inflammatory response, due to local tissue damage and the shedding of malignant cells into the blood and lymphocytic circulation although meticulous surgical manipulation. Many evidences suggest that several factors during the perioperative period can affect the immune system.
These could be attributed to the surgery per se, pain, anxiety, hypothermia, blood transfusion, anesthetic technique, and anesthetic drugs .Impairment in the immune system may allow malignant cells to escape immuno-surveillance and metastasize in the perioperative period.As well as increase the risk of postoperative complications, such as systemic inflammatory response syndrome, sepsis, and multi-organ failure.
Previous retrospective clinical studies of both breast and prostate cancer surgery have suggested an association between anaesthetic technique and cancer recurrence.
However ,other retrospective trials on various forms of cancer have shown no such benefit.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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DK
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Mansoura, DK, Egypt, 050
- Mansoura University Hospitals, Ear Nose Thorat Department, Mansoura University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- American Society of Anesthesiologists physical status I- III
- Scheduled for total laryngectomy.
Exclusion Criteria:
- Patients refusal.
- Morbid obese patients (body mass index >40 kg/m2).
- Allergy to local anesthetics agents used.
- Severely altered consciousness level.
- Psychiatric disorders.
- Severe or uncompensated cardiovascular disease.
- Severe renal disease.
- Severe hepatic disease.
- Severe endocrinal diseases.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Propofol group
Patients receive only intravenous anesthetics
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Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.
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Placebo komparator: Isoflurane group
Patients receive isoflurane /fentanyl anesthesia
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Anesthesia was maintained with isoflurane at a concentration of 2-2.5%.
fentanyl 50 ug increments
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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CD3 plasma level
Tidsramme: for 7 days after procedure
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Venous blood samples will be collected.
The extracted venous blood samples will be mixed evenly in a special anti-coagulation test tube and stored in a refrigerator (at 4C).Flow cytometer will be used to detect the level of CD3+
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for 7 days after procedure
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Heart rate
Tidsramme: for 5 hours during the procedure
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Intraoperative heart rate changes
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for 5 hours during the procedure
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Blood pressure
Tidsramme: for 5 hours during the procedure
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Intraoperative blood pressure changes
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for 5 hours during the procedure
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Peripheral oxygen saturation measured with pulse oximetry
Tidsramme: for 5 hours during the procedure
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Intraoperative peripheral oxygen saturation changes as measured with pulse oximetry
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for 5 hours during the procedure
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Reem A El Sharkawy, MD, Lecturer of Anesthesia and Surgical Intensive care
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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 (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R/16.01.112
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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