Concentrations of Remifentanil for Extubation (REMEX)
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|ClinicalTrials.gov Identifier: NCT02711904|
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : March 17, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Cough||Drug: Extubation U Drug: Extubation T||Phase 4|
Phase of the study:
Drug: U Extubation
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
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:
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.
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).
A patient was recruited between the period of January 2011 and July 2012.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Two Plasma Concentrations of Remifentanil Through Target Controlled Anesthesia on Frequency and Intensity of Coughing During Extubation: Randomized Controlled Clinical Trial|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||July 2012|
Active Comparator: Extubation U
Remifentanil concentration between 2 - 3 ng/ml.
Drug: Extubation U
Dose of remifentanil according to the randomization; the infusions that were used to reach the PC target were:
Other Name: Ultiva
Experimental: Extubation T
Remifentanil concentration between 3 - 4 ng/ml
Drug: Extubation T
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:
Other Name: Ultiva
- Cough [ Time Frame: 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.
- 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).
- Wake time. [ Time Frame: 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.
- Ramsay scale at the time of extubation [ Time Frame: 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711904
|Instituto Para Niños Ciegos y Sordos del Valle del Cauca|
|Santiago de Cali, Valle del Cauca, Colombia, 288 00|
|Principal Investigator:||LUIS A TAFUR, MD||Seganest|
|Study Director:||Eduardo Lema, MD||Seganest|