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
調査の概要
詳細な説明
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.
研究の種類
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
British Columbia
-
Vancouver、British Columbia、カナダ、V6Z 1Y6
- St Paul's Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
|
2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia
|
|
実験的：デキサメタゾン
|
One dose of 8 mg of Dexamethasone intravenously at induction of anesthesia
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Plasma Cortisol level.
時間枠：One, eight and twenty-four hours following Dexamethasone administration.
|
One, eight and twenty-four hours following Dexamethasone administration.
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence of postoperative nausea and vomiting.
時間枠：Twenty-four hours following surgery.
|
Twenty-four hours following surgery.
|
|
Pain intensity measured on the visual analogue scale.
時間枠：Twenty-four hours following surgery
|
Twenty-four hours following surgery
|
|
Plasma Estradiol level.
時間枠：One, eight and twenty-four hours following dexamethasone administration.
|
One, eight and twenty-four hours following dexamethasone administration.
|
|
Plasma Progesterone level.
時間枠：One, eight and twenty-four hours following dexamethasone administration
|
One, eight and twenty-four hours following dexamethasone administration
|
|
Plasma ACTH level
時間枠：One, eight and twenty-four hours following dexamethasone administration.
|
One, eight and twenty-four hours following dexamethasone administration.
|
協力者と研究者
捜査官
- 主任研究者：Jill A Osborn, MD、St Paul's Hospital, Vancouver and University of British Columbia
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SPH-1515-DA
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Dexamethasoneの臨床試験
-
Eye Surgeons of IndianaOcular Therapeutix, Inc.完了
-
Bristol-Myers SquibbAbbVie; Celgene完了多発性骨髄腫アメリカ, ドイツ, イタリア, ギリシャ, オランダ, オーストラリア, スペイン, ポーランド, カナダ, フランス, 日本
-
University of Chicago募集急性リンパ芽球性白血病 | リンパ芽球性白血病 | ph+ 急性リンパ芽球性白血病アメリカ
-
British Columbia Cancer AgencyHoffmann-La Roche積極的、募集していない