Concentrations of Remifentanil for Extubation (REMEX)

Seganest

Status and phase: Completed; Phase 4

Conditions: Cough

Treatments: Drug: Extubation U; Drug: Extubation T

Study type: Interventional

Funder types: Other

Identifiers

NCT02711904

SEGANEST

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

Extubation U

Active Comparator group

Description:

Remifentanil concentration between 2 - 3 ng/ml.

Treatment:

Drug: Extubation U

Extubation T

Experimental group

Description:

Remifentanil concentration between 3 - 4 ng/ml

Treatment:

Drug: Extubation T