Clinical trial NCT02711904: Concentrations of Remifentanil for Extubation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cough
Keywords: Extubation
Cough
Target Controlled Anesthesia (TACAN)
Lead sponsor: Seganest
Sponsor class: OTHER
Collaborators: name: Instituto Para Ninos Ciegos y Sordos del Valle del Cauca
First posted: 2016-03-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cough
timeFrame: 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 outcomes:
measure: Wake time.
timeFrame: 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.
measure: Ramsay scale at the time of extubation
timeFrame: During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered
Other outcomes:
Locations:
city: Santiago de Cali
country: Colombia
facility: Instituto Para Niños Ciegos y Sordos del Valle del Cauca
state: Valle del Cauca
Study officials:
affiliation: Seganest
name: LUIS A TAFUR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seganest
name: Eduardo Lema, MD
role: STUDY_DIRECTOR
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