Concentrations of Remifentanil for Extubation
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Extubation U; Extubation T
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Ultiva; Ultiva
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Extubation; Cough; Target Controlled Anesthesia (TACAN)