NCT02711904

Concentrations of Remifentanil for Extubation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Seganest · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	Extubation U	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.
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: * 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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-01-01
• Completion: 2012-07-01
• First posted: 2016-03-17
• Last updated: 2016-03-17

Locations

1 site across 1 country: Colombia