A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain (RemivsDex)
2016年10月26日 更新者：The Cleveland Clinic
This will be a randomized blinded clinical trial.
Patients will be randomized to receive either a remifentanil or dexmedetomidine infusion for general anesthesia.
The anesthesia team will know the result of randomization at induction.
Data will be gathered by research personnel who will be blinded to the anesthetic method used.
Patients will be blinded to the anesthetic they receive till they are discharged from the PACU when they will have the option to be unblinded.
The Data Safety and -Toxicity Committee will review all serious adverse events and toxicity reports as well as annual reviews.
調査の概要
詳細な説明
Anesthesia for craniotomy presents a unique challenge to the anesthesiologist.
Anesthesia for neurosurgical procedures should provide optimal surgical conditions while maintaining appropriate cerebral oxygen supply and stable systemic hemodynamics.
(1) It is important to prevent patient response to noxious stimuli during the procedure like pinning, drilling of the bone, opening and manipulation of the dura etc., avoid coughing and bucking during surgery and during extubation thus necessitating a deeper level of anesthesia and analgesia.
At the same time it is desirable to have the patient fully awake toward the end of the surgery in order to facilitate neurologic evaluation.
Management of the above presents a challenge during induction, maintenance and extubation and also during multiple critical stages of surgery Fear of the side effects of analgesic drugs frequently leads to the under-treatment of post-craniotomy pain.
(2) Nevertheless, this pain continues to be commonly observed, is frequently severe, and, if unrelieved, may cause distress for the neurosurgical patient and serious complications for the operative brain.
(2) There is a need for larger trials to delineate safety and efficacy of analgesic therapies with a focus on short- and long-term outcomes.
研究の種類
介入
入学 (実際)
142
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
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Cleveland、Ohio、アメリカ、44195
- The Cleveland Clinic Foundation
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
Patients who undergo general anesthesia for elective surgical excision of a brain tumor with following specifications:
- Age: Older than 18
- Primary and redo cases will be included
- Duration of surgery not exceeding 6 hrs.
Exclusion Criteria:
- Patient refusal
- Emergency craniotomy
- Morbid obesity
- Uncontrolled hypertension - DBP more than 110
- Cardiac conduction defects
- Patients with chronic pain.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Remifentanil
Remifentanil 0.08-0.15MCG/KG/MIN
INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
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Remifentanil 0.08-0.15MCG/KG/MIN
INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
他の名前：
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アクティブコンパレータ：Dexmedetomidine
a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
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a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hemodynamics
時間枠：15, 30, 45, 60, and 90 minutes after extubation.
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Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg).
This outcome was analyzed using a repeated measures ANOVA approach.
In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.
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15, 30, 45, 60, and 90 minutes after extubation.
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Postoperative Pain
時間枠：15, 30, 45, 60, and 90 minutes after extubation.
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Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable.
This outcome was analyzed using a repeated measures ANOVA approach.
In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.
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15, 30, 45, 60, and 90 minutes after extubation.
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Total Opioid Consumption
時間枠：Initial 90 minutes of recover after surgery
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Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.
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Initial 90 minutes of recover after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Heart Rate
時間枠：15, 30, 45, 60, and 90 minutes after extubation.
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Heart rate was determined from the arterial catheter and measured as beats per minute.
This outcome was analyzed using a repeated measures ANOVA approach.
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15, 30, 45, 60, and 90 minutes after extubation.
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Modified Short Orientation Memory Concentration Test (SOMCT)
時間枠：15, 30, 45, 60, and 90 minutes after extubation.
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The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits.
SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function).
Scores > 20 are considered normal.
This outcome was analyzed using a repeated measures ANOVA approach.
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15, 30, 45, 60, and 90 minutes after extubation.
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Aldrete Score
時間枠：15, 30, 45, 60, and 90 minutes after extubation.
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The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit.
The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness.
This outcome was analyzed using a repeated measures ANOVA approach.
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15, 30, 45, 60, and 90 minutes after extubation.
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Nursing Workload Comparison
時間枠：90 minutes after extubation
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To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system.
This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).
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90 minutes after extubation
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Drug Stop Time to Open Eyes
時間枠：Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.
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time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery
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Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.
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Drug Stop Time to Recall
時間枠：Time between extubation until patients could say their names.
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Time between extubation until patients could say their names.
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Time between extubation until patients could say their names.
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Drug Stop Time to Fitness to Discharge
時間枠：Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.
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Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.
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End Case to Post Anesthesia Care Unit (PACU) Discharge
時間枠：End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.
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Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU.
This outcome is the amount of time (minutes) from end case to PACU discharge.
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End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.
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Postoperative Nausea
時間枠：Whether patients had nausea or not, from anesthesia stop time until hospital discharge.
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Indicator of whether patients had nausea or not
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Whether patients had nausea or not, from anesthesia stop time until hospital discharge.
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Postoperative Vomitting
時間枠：Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.
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Indicator of whether patients had postoperative vomiting.
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Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.
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Postoperative Shivering
時間枠：Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.
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Indicator of whether patients had postoperative shivering.
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Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Shobana Rajan, MD、The Cleveland Clinic
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年7月1日
一次修了 (実際)
2014年3月1日
研究の完了 (実際)
2014年3月1日
試験登録日
最初に提出
2010年12月22日
QC基準を満たした最初の提出物
2011年1月3日
最初の投稿 (見積もり)
2011年1月4日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年12月20日
QC基準を満たした最後の更新が送信されました
2016年10月26日
最終確認日
2016年10月1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
- 10-1056
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未定
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