Concentrations of Remifentanil for Extubation

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effect of Two Plasma Concentrations of Remifentanil Through Target Controlled Anesthesia on Frequency and Intensity of Coughing During Extubation: Randomized Controlled Clinical Trial

Conditions
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Cough

Intervention / Treatment
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* Drug: Extubation U
* Drug: Extubation T


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extubation U<br>Remifentanil concentration between 2 - 3 ng/ml. | Drug: Extubation U<br>* Dose of remifentanil according to the randomization; the infusions that were used to reach the PC target were: 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.<br>* Other names: Ultiva;|
| Experimental: Extubation T<br>Remifentanil concentration between 3 - 4 ng/ml | Drug: Extubation T<br>* 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: 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.<br>* Other names: Ultiva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough | Number of episodes and duration of cough that occur when the patient responds to verbal stimulus and extubated. Cough Scale Grade 0 = No cough Grade 1 = Mild (only episode of cough) Grade 2 = Moderate (more than 1episode of cough during less than 5 seconds) Grade 3 = Severe (More than one episode of cough that lasted more than 5 seconds or purposeless movements of the extremities). | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wake time. | 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 | Ramsay scale: score objective system for measuring drug-induced sedation Score 1: Anxious or restless or both Score 2: Cooperative, orientated and tranquil Score 3: Responding to commands Score 4: Brisk response to stimulus Score 5: Sluggish response to stimulus Score 6: No response to stimulus | During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extubation, Cough, Target Controlled Anesthesia (TACAN)