Ignite Creation Date:
2024-05-06 @ 8:19 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02711904
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2013-08-27
Brief Title:
Concentrations of Remifentanil for Extubation
Sponsor:
Seganest
Organization:
Seganest
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMEX
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 ngml through the technique of target controlled anesthesia
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 ngml through the technique of target controlled anesthesia
Detailed Description:
Phase of the study
Phase IV
Intervention
Drug U Extubation
Other Names
Concentration 2 - 3 ngml Dose of remifentanil according to the randomization Letter U between 2 - 3 ngml The infusions that were used to reach the PC target were Group U 2 - 3 ngml 20 years old - 60 mcgKgh 30 years old - 57 mcgKgh 40 years old - 53 mcgkgh 50 years old - 50 mcgkgh 60 years old - 46 mcgkgh 70 years old - 43 mcgkgh 80 years old - 40 mcg kgh
Drug Extubation T
Other Names
Concentration 3 - 4 ngml Dose of infusion of remifentanil to reach a PC 3 - 4 ngml 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 ngml 20 years old - 90 mcgKgh 30 years old - 85 mcgKgh 40 years old - 80 mcgkgh 50 years old - 75 mcgkgh 60 years old - 70 mcgkgh 70 years old - 65 mcgkgh 80 years old - 60 mcg kgh
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 ngml group U and concentration of remifentanil of 3 - 4 ngml group T
Recruitment
A patient was recruited between the period of January 2011 and July 2012
Phase IV
Intervention
Drug U Extubation
Other Names
Concentration 2 - 3 ngml Dose of remifentanil according to the randomization Letter U between 2 - 3 ngml The infusions that were used to reach the PC target were Group U 2 - 3 ngml 20 years old - 60 mcgKgh 30 years old - 57 mcgKgh 40 years old - 53 mcgkgh 50 years old - 50 mcgkgh 60 years old - 46 mcgkgh 70 years old - 43 mcgkgh 80 years old - 40 mcg kgh
Drug Extubation T
Other Names
Concentration 3 - 4 ngml Dose of infusion of remifentanil to reach a PC 3 - 4 ngml 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 ngml 20 years old - 90 mcgKgh 30 years old - 85 mcgKgh 40 years old - 80 mcgkgh 50 years old - 75 mcgkgh 60 years old - 70 mcgkgh 70 years old - 65 mcgkgh 80 years old - 60 mcg kgh
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 ngml group U and concentration of remifentanil of 3 - 4 ngml group T
Recruitment
A patient was recruited between the period of January 2011 and July 2012
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None