- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01045876
The Effect of Dexamethasone on Cortisol Levels in Patients Undergoing Thyroid Surgery
The Effect of Dexamethasone on Plasma Cortisol Levels, Pain and PONV in Female Patients Undergoing Thyroid Surgery
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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British Columbia
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Vancouver, British Columbia, Kanada, V6Z 1Y6
- St Paul's Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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:
- A diagnosis of anxiety, depression or bipolar disorder
- Disorders of the central nervous system, pituitary gland or hypothalamic-pituitary-adrenal axis
- Diabetes mellitus
- Pathological conditions affecting cortisol metabolism, including liver disease
- Chronic renal failure
- Alcoholism
- Obesity
- Anorexia nervosa/ starvation
- 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:
- Patients taking exogenous steroid medication which would suppress normal cortisol production.
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Placebo-Komparator: Placebo
|
2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia
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Experimental: Dexamethason
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One dose of 8 mg of Dexamethasone intravenously at induction of anesthesia
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Plasma Cortisol level.
Zeitfenster: One, eight and twenty-four hours following Dexamethasone administration.
|
One, eight and twenty-four hours following Dexamethasone administration.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Incidence of postoperative nausea and vomiting.
Zeitfenster: Twenty-four hours following surgery.
|
Twenty-four hours following surgery.
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Pain intensity measured on the visual analogue scale.
Zeitfenster: Twenty-four hours following surgery
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Twenty-four hours following surgery
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Plasma Estradiol level.
Zeitfenster: One, eight and twenty-four hours following dexamethasone administration.
|
One, eight and twenty-four hours following dexamethasone administration.
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Plasma Progesterone level.
Zeitfenster: One, eight and twenty-four hours following dexamethasone administration
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One, eight and twenty-four hours following dexamethasone administration
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Plasma ACTH level
Zeitfenster: One, eight and twenty-four hours following dexamethasone administration.
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One, eight and twenty-four hours following dexamethasone administration.
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jill A Osborn, MD, St Paul's Hospital, Vancouver and University of British Columbia
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des endokrinen Systems
- Nebennierenerkrankungen
- Nebennieren-Insuffizienz
- Physiologische Wirkungen von Arzneimitteln
- Autonome Agenten
- Agenten des peripheren Nervensystems
- Entzündungshemmende Mittel
- Antineoplastische Mittel
- Antiemetika
- Magen-Darm-Mittel
- Glukokortikoide
- Hormone
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Antineoplastische Mittel, hormonell
- Dexamethason
Andere Studien-ID-Nummern
- SPH-1515-DA
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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