Concentrations of Remifentanil for Extubation (REMEX)
Effect of Two Plasma Concentrations of Remifentanil Through Target Controlled Anesthesia on Frequency and Intensity of Coughing During Extubation: Randomized Controlled Clinical Trial
Condition of the State: (terminated, recruiting, etc.) Terminated
Study Design: Main Objective:
Compare the frequency and intensity of coughing at the time of extubation with two infusions of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through the technique of target controlled anesthesia
調査の概要
詳細な説明
Phase of the study:
Phase IV
Intervention:
Drug: U Extubation
Other Names:
Concentration 2 - 3 ng/ml Dose of remifentanil according to the randomization: Letter U between 2 - 3 ng/ml. The infusions that were used to reach the (PC) target were: Group U = 2 - 3 ng/ml. 20 years old - 6.0 mcg/Kg/h, 30 years old - 5.7 mcg/Kg/h, 40 years old - 5.3 mcg/kg/h, 50 years old - 5.0 mcg/kg/h, 60 years old - 4.6 mcg/kg/h, 70 years old - 4.3 mcg/kg/h, 80 years old - 4.0 mcg kg/h.
Drug: Extubation T
Other Names:
Concentration 3 - 4 ng/ml Dose of infusion of remifentanil to reach a (PC) 3 - 4 ng/ml, in the following manner: The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient. The remifentanil dose was adjusted according to the randomization: Group T = 3 - 4 ng/ml. 20 years old - 9.0 mcg/Kg/h, 30 years old - 8.5 mcg/Kg/h, 40 years old - 8.0 mcg/kg/h, 50 years old - 7.5 mcg/kg/h, 60 years old - 7.0 mcg/kg/h, 70 years old - 6.5 mcg/kg/h, 80 years old - 6.0 mcg kg/h.
Number of arms:
2
Masking:
The patient had masking with regards to the anesthetic procedure from the unfamiliarity per se of the same and by agents used in this that induced anxiolysis and hypnosis.
To guarantee the masking to the viewer, which was the treating anesthesiologist, a nurse was trained in the adjustment of the infusion balloon. Ten minutes before concluding the procedure and by request of the anesthesiologist, the nurse proceeded to locate balloon in such a way that the infusion could not be seen by the anesthesiologist, then opened the envelope and adjusted the infusion according to the randomization (U) o (T). The evaluation of the cough, its intensity and the Ramsay were under the care of the anesthesiologist, who was unaware of the awakening infusion.
Allocation:
Two were allocated for the use: Concentration of remifentanil of 2 - 3 ng/ml (group U) and concentration of remifentanil of 3 - 4 ng/ml (group T).
Recruitment:
A patient was recruited between the period of January 2011 and July 2012.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Valle del Cauca
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Santiago de Cali、Valle del Cauca、コロンビア、288 00
- Instituto Para Niños Ciegos y Sordos del Valle del Cauca
-
-
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:
- All patients aged 18-70 years
- Risk Scale American Society of Anaesthesiologists physical status classification (ASA) I and II
- Undergoing elective ear surgery
Exclusion Criteria:
- Patients who are contraindicated remifentanil
- Patients undergoing emergency surgery
- Pulmonary Pathology (ASTHMA - COPD)
- Index of body mass greater than 35
- Background of respiratory failure three weeks prior to the procedure
- Smokers
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
- 主な目的：防止
- 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 |
|---|---|
|
アクティブコンパレータ：Extubation U
Remifentanil concentration between 2 - 3 ng/ml.
|
Dose of remifentanil according to the randomization; the infusions that were used to reach the PC target were:
他の名前：
|
|
実験的：Extubation T
Remifentanil concentration between 3 - 4 ng/ml
|
Dose of infusion of remifentanil to reach a PC 3 - 4 ng/ml, in the following manner: The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient. The remifentanil dose was adjusted according to the randomization:
他の名前：
|
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 |
|---|---|---|
|
Cough
時間枠：It is evaluated by the scale of cough over a two hour period after surgery: is assessed at 5 minutes turned off the halogenated inhalation anesthetics, thereafter every minute until the patient responds to verbal stimulus and can be extubated
|
Number of episodes and duration of cough that occur when the patient responds to verbal stimulus and extubated. Cough Scale
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It is evaluated by the scale of cough over a two hour period after surgery: is assessed at 5 minutes turned off the halogenated inhalation anesthetics, thereafter every minute until the patient responds to verbal stimulus and can be extubated
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Wake time.
時間枠：During two hours after surgery, five minutes after turning off halogenated inhaled anesthetics, then every minute until the patient opens his eyes and is extubated.
|
When vaporizer where closed until the patient responds to the verbal stimulus and is extubated. Defined as the time taken to open eyes after having turned off the halogenated inhalation anesthetics. |
During two hours after surgery, five minutes after turning off halogenated inhaled anesthetics, then every minute until the patient opens his eyes and is extubated.
|
|
Ramsay scale at the time of extubation
時間枠：During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered
|
Ramsay scale: score objective system for measuring drug-induced sedation
|
During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：LUIS A TAFUR, MD、Seganest
- スタディディレクター：Eduardo Lema, MD、Seganest
出版物と役立つリンク
一般刊行物
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研究の完了 (実際)
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