Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

The Effect of Dexamethasone on Cortisol Levels in Patients Undergoing Thyroid Surgery

18. april 2016 oppdatert av: Jill Osborn, St. Paul's Hospital, Canada

The Effect of Dexamethasone on Plasma Cortisol Levels, Pain and PONV in Female Patients Undergoing Thyroid Surgery

Many drugs are used to prevent nausea and vomiting and pain after surgery. In this study the investigators will be looking at a drug, dexamethasone, which is commonly used to prevent nausea and vomiting and pain after surgery but has other side effects. Dexamethasone is a man-made drug that is commonly used during surgery but also can affect naturally occuring hormones. In this study the investigators will be looking at dexamethasone's effect on a number of naturally occuring hormones over a twenty four hour period after thyroid surgery. The investigators hypothesize that plasma cortisol levels will be decreased following administration of dexamethasone.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Purpose To examine the effect of dexamethasone, on plasma cortisol levels, postoperative pain, nausea and vomiting in patients undergoing thyroid surgery.

Hypothesis That dexamethasone administered at induction of anesthesia will result in reduced plasma cortisol levels, postoperative pain, nausea and vomiting.

Justification Dexamethasone is a synthetic steroid medication used routinely to prevent nausea and vomiting in patients undergoing general anesthetic. Administration of exogenous steroids can suppress production of endogenous steroids including cortisol.

Currently, no data exists describing the degree of suppression of cortisol production by a single preoperative dose of dexamethasone. This information would guide physicians prescribing dexamethasone in the perioperative period.

Objectives To compare plasma cortisol levels in patients receiving dexamethasone versus placebo at induction of anesthesia. To investigate the effect of dexamethasone on postoperative pain, nausea and vomiting.

Research Methods A prospective, randomized, controlled, double-blinded study conducted at a single center. Thirty patients will be recruited and randomly assigned to dexamethasone or placebo groups, in accordance with sample size calculations. A placebo group is necessary to eliminate the effects of potential confounding factors.

Statistical Analysis An interim analysis will be conducted to confirm the sample size calculation. Plasma cortisol level will be analyzed using 2-way analysis of variance (ANOVA). Secondary outcome measures will be analyzed with appropriate parametric or nonparametric methods.

Studietype

Intervensjonell

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St Paul's Hospital

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Female adult patients
  • Undergoing thyroid surgery
  • Euthyroid patients
  • Qualify as Class I or II according to the American Society of Anesthesiologists physical status classification system
  • Written informed consent

Exclusion Criteria:

  • Patients who have medical conditions associated with abnormalities of the hypothalamic-pituitary-adrenal axis which might alter plasma cortisol levels will be excluded from the study. This category includes the following conditions:

    1. A diagnosis of anxiety, depression or bipolar disorder
    2. Disorders of the central nervous system, pituitary gland or hypothalamic-pituitary-adrenal axis
    3. Diabetes mellitus
    4. Pathological conditions affecting cortisol metabolism, including liver disease
    5. Chronic renal failure
    6. Alcoholism
    7. Obesity
    8. Anorexia nervosa/ starvation
    9. High estrogen states, including pregnancy or use of OCP

  • Patients taking medication which might alter the normal function of the hypothalamic-pituitary-adrenal axis. This category includes:

    1. Patients taking exogenous steroid medication which would suppress normal cortisol production.
    2. Patients taking medication which alters steroid metabolism, including barbiturates, phenytoin and rifampicin.
  • Patients who have a known history of allergy, sensitivity or any other form of reaction to dexamethasone will be excluded from this study as they would be at risk of further reaction to dexamethasone.
  • Patients who have previously been included in this study will be excluded from further recruitment.
  • Patients who will undergo lateral neck dissection in association with the thyroid surgery will be excluded from the study as they will experience greater pain levels.
  • Patients who participate in other clinical studies during this study or in the 14 days prior to admission to this study will be excluded

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Annen: Placebo
2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia
Eksperimentell: Deksametason
Legemiddel: Dexamethasone
One dose of 8 mg of Dexamethasone intravenously at induction of anesthesia

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Plasma Cortisol level.
Tidsramme: One, eight and twenty-four hours following Dexamethasone administration.
One, eight and twenty-four hours following Dexamethasone administration.

Sekundære resultatmål

Resultatmål
Tidsramme
Incidence of postoperative nausea and vomiting.
Tidsramme: Twenty-four hours following surgery.
Twenty-four hours following surgery.
Pain intensity measured on the visual analogue scale.
Tidsramme: Twenty-four hours following surgery
Twenty-four hours following surgery
Plasma Estradiol level.
Tidsramme: One, eight and twenty-four hours following dexamethasone administration.
One, eight and twenty-four hours following dexamethasone administration.
Plasma Progesterone level.
Tidsramme: One, eight and twenty-four hours following dexamethasone administration
One, eight and twenty-four hours following dexamethasone administration
Plasma ACTH level
Tidsramme: One, eight and twenty-four hours following dexamethasone administration.
One, eight and twenty-four hours following dexamethasone administration.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

St. Paul's Hospital, Canada

Etterforskere

  • Hovedetterforsker: Jill A Osborn, MD, St Paul's Hospital, Vancouver and University of British Columbia

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

1. mai 2010

Primær fullføring (Forventet)

1. februar 2014

Studiet fullført (Forventet)

1. februar 2016

Datoer for studieregistrering

Først innsendt

8. januar 2010

Først innsendt som oppfylte QC-kriteriene

8. januar 2010

Først lagt ut (Anslag)

11. januar 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. april 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. april 2016

Sist bekreftet

1. april 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SPH-1515-DA

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Adrenal insuffisiens

Kliniske studier på Dexamethasone

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in China

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere