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Effect of Remifentanil on the Recovery Profile After Prolonged Head and Neck Surgery

2015年4月14日 更新者:Suhitharan Thangavelautham、Singapore General Hospital
Opioid tolerance in the perioperative period is inevitable especially with ultra-short acting agents such as remifentanil. Existing evidence had shown that opioid induced hyperalgesia due to neuroplastic changes in the central as well as peripheral nervous system leads to sensitization of pro-nociceptive pathways. However there has been a controversy of occurrence of such tolerance following the use of remifentanil and the quality of recovery as compared to conventional opioids. The investigators evaluated the occurrence of opioid tolerance and other significant adverse effects with remifentanil in subjects undergoing head and neck surgeries. The investigators studied ASA physical status I and II adult subjects undergoing elective head and neck procedures, under general anesthesia with minimum expected duration of 2 hours. The remifentanil infusion was used in one group and intermittent boluses of morphine or fentanyl administered in another group. They were evaluated for immediate post-operative pain by using numerical rating scale (NRS), the opioid consumption, post-operative nausea, vomiting, other significant adverse effects of remifentanil and the time to discharge from PACU.

調査の概要

詳細な説明

We have studied 222 of you between the age of 21 and 80 years, over a period of 2 years at Singapore General Hospital, Singapore. All of you were ASA I to II and scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia. The methodology of this observational study was approved by the International review Board at Singapore General Hospital, Singapore. Informed consent was obtained from you prior to the procedure. If you had previous history of either drug or alcohol abuse, have been using opioids for long term, mental disorder with difficult to understand pain scoring system, ASA physical status of III and above, your surgical procedure warranting elective postoperative ventilation you would have been excluded from this study. The study was not randomized and the choice of intra-operative opioids were left to the discretion of anesthesiologist attending you.

You were not premedicated and instructed about 11 point numerical rating score after reaching induction room. Upon arrival in the operating room, you were monitored with EKG, non-invasive arterial pressure and pulse oxymetry. The attending anesthesiologist gave you either Remifentanil or conventional opioids at standard doses from the induction of anesthesia to end of surgery. Sevoflurane, desflurane or isoflurane with oxygen air mixture were utilized to maintain anesthesia at the minimum alveolar concentration of 0.8 to 1.2 . Choice of opioid, volatile agent, muscle relaxants, airway was left to the discretion of the anesthesiologist attending the patient. Parameters including type of volatile anesthetic agent, method of air way establishment, the duration of surgery, the remifentanil used (microgram.kg-1 ) and amount of morphine or fentanyl (microgram.kg-1) were documented. Upon arrival to the PACU you were assessed for the pain.

For the first 15 minutes behavioral score (0 - calm patient with no verbal or behavioral manifestation of pain, 1 - behavioral or verbal expression of pain, and 2 - intense behavioral or verbal manifestation [crying or extreme agitation]) were utilized and subsequently numerical rating scale (NRS) was used for every 5 minutes until discharge from the PACU.

Intravenous morphine or fentanyl was used to treat immediate post-operative pain in PACU till the NRS is less than or equal to 3 as per PACU acute pain management protocol. Maximum NRS of pain, amount of morphine or fentanyl used for rescue analgesia, occurrence of either nausea or vomiting and the antiemetic used was gathered every 15 minutes. Upon discharge from the PACU, total opioids consumed, duration of the PACU (defined by time since admission to decision made for discharge by PACU anesthesiologists, to rule out the prolong PACU stay from other reasons) and occurrence of other potential side effects that affect the quality of recovery such as drowsy, nausea, vomiting, shivering and evidence of respiratory suppression ( desaturation or bradypnea ) were documented.

Our primary outcome was amount of opioids used in PACU and the secondary outcomes were the duration of PACU stay and the adverse effects of remifentanil that influence the recovery as stated above.

研究の種類

観察的

入学 (実際)

222

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

      • Singapore、シンガポール、169608
        • Department of Anesthesia Singapore General Hospital

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

21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

サンプリング方法

非確率サンプル

調査対象母集団

We studied 222 adult subjects between 21 and 80 years, over two years at Singapore General Hospital, Singapore. All subjects were ASA I to II and scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia.

説明

Inclusion Criteria:

Patients with ASA I to II, scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia

Exclusion Criteria:

previous history of either drug or alcohol abuse those who have been using opioids for long term mental disorder with difficult to understand pain scoring system ASA physical status of III and above surgical procedure warranting elective postoperative ventilation

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

  • 観測モデル:ケースコントロール
  • 時間の展望:見込みのある

コホートと介入

グループ/コホート
介入・治療
remifentanil group
Group received intra op remifentanil infusion
The remifentanil infusion was used intra operatively in remifentanil group and intermittent boluses of morphine or fentanyl administered for conventional opioid group
conventional opioid gropup
Group received only conventional opioids and No infusion of remifentanil

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
Amount of opioids used in PACU in morphine equivalent
時間枠:90 minutes
average time spent in PACU
90 minutes

二次結果の測定

結果測定
メジャーの説明
時間枠
Duration of PACU
時間枠:90 minutes
average time spent in PACU
90 minutes
Adverse effects of remifentanil
時間枠:90 minutes
Occurrence of following adverse events such Drowsy, nausea, vomiting, shivering and evidence of respiratory suppression ( desaturation or bradypnea ) were documented.
90 minutes

協力者と研究者

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スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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8月1日

一次修了 (実際)

2013年7月1日

研究の完了 (実際)

2013年7月1日

試験登録日

最初に提出

2015年4月7日

QC基準を満たした最初の提出物

2015年4月14日

最初の投稿 (見積もり)

2015年4月15日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年4月15日

QC基準を満たした最後の更新が送信されました

2015年4月14日

最終確認日

2015年4月1日

詳しくは

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。

痛みの臨床試験

Remifentanilの臨床試験

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