Evaluation of the Effect of Venous Diameter Measurement by Ultrasonography on Pain and Withdrawal Response (VDIAMETER)
During general anesthesia, intravenous (IV) medications can disrupt the patient's comfort by causing a pain sensation or a withdrawal response in the heart. Propofol and rocuronium are among the most common causes of this condition.
In recent years, the use of ultrasonography (USG) in anesthesia has become widespread with the rapid advancement of technology. The use of the patient's head is a non invasive method.
This study is aimed to evaluate whether the size of the venous diameter assessed by ultrasonography in our study is an effect on pain and withdrawal response after drug injections.
調査の概要
詳細な説明
The study was conducted in patients who underwent surgical procedures under general anesthesia by obtaining consent from the Adnan Menderes University Medical Faculty Ethics Board and written consent from the patients and then being admitted to the ASA I-II age group 18-70 years of age.
Patients with peripheric vascular disease, vasculitis, rheumatologic disease, non-cooperative, under the age of 18 and over 70, ASA III and above, allergic to general anesthetic agents and refusing to participate in the study were excluded from the study.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
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Aydın、七面鳥、09100
- Adnan Menderes University Training and Research Hospital
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-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
18- 70 years of ASA (American society of anesthesiology) physical status I- II who were to undergo various elective operations
Exclusion Criteria:
Rheumatologic disease Peripheric vascular disease Vasculitis Patients with chronic pain syndrome, Patients with neurologic deficits, Patients with thrombophlebitis, Patients with difficult venous access, Patients with allergy
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
- 観測モデル：ケースクロスオーバー
- 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 |
|---|---|
|
Group 1
Venous diameter measurements were made via the USG in the hand dorsum. Transverse venous diameter ≤2mm was defined group 1. Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded. |
Four poin scala 0=No Pain
Withdrawal movements
Hemodynamic data were recorded in the patients taken in the operation room.
(T0).
Hemodynamic values (T1) measured 1 minute after administration of intravenous propofol were recorded.
Hemodynamic values (T2) measured 1 minute after administration of intravenous rocuronium were recorded.
Hemodynamic values (T3) measured 1 minute after administration of endotracheal intubation were recorded.
|
|
Group 2
Venous diameter measurements were made via the USG in the hand dorsum.Transverse venous diameter >2mm was defined group 2.Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded. |
Four poin scala 0=No Pain
Withdrawal movements
Hemodynamic data were recorded in the patients taken in the operation room.
(T0).
Hemodynamic values (T1) measured 1 minute after administration of intravenous propofol were recorded.
Hemodynamic values (T2) measured 1 minute after administration of intravenous rocuronium were recorded.
Hemodynamic values (T3) measured 1 minute after administration of endotracheal intubation were recorded.
|
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 |
|---|---|---|
|
The injection pain due to propofol
時間枠：6 month
|
Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).
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6 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The withdrawal movement due to rocuronium
時間枠：6 month
|
Withdrawal movements are scored as follows: (a) no movement response, (b) movement limited to the wrist, (c)movement limited to the elbow/shoulder, or (d) generalized movement response.
|
6 month
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
キーワード
その他の研究ID番号
- VASCULAR DIAMETER
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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
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Dexa Medica Group完了
Pain Scoreの臨床試験
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Brigham and Women's HospitalBiofourmis Inc.積極的、募集していない