Concentrations of Remifentanil for Extubation

Cough Clinical Trial

— REMEX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711904
• Other study ID #: SEGANEST
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2013
• Last updated: March 16, 2016
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: March 2016
• Source: Seganest
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cough

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	Instituto Para Niños Ciegos y Sordos del Valle del Cauca	Santiago de Cali	Valle del Cauca

Sponsors (2)

Lead Sponsor	Collaborator
Seganest	Instituto Para Ninos Ciegos y Sordos del Valle del Cauca

Country where clinical trial is conducted

Colombia, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough	Number of episodes and duration of cough that occur when the patient responds to verbal stimulus and extubated.; Cough Scale; Grade 0 = No cough; Grade 1 = Mild (only episode of cough); Grade 2 = Moderate (more than 1episode of cough during less than 5 seconds); Grade 3 = Severe (More than one episode of cough that lasted more than 5 seconds or purposeless movements of the extremities).	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	No
Secondary	Wake time.	When vaporizer where closed until the patient responds to the verbal stimulus and is extubated.; Defined as the time taken to open eyes after having turned off the halogenated inhalation anesthetics.	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.	No
Secondary	Ramsay scale at the time of extubation	Ramsay scale: score objective system for measuring drug-induced sedation; Score 1: Anxious or restless or both; Score 2: Cooperative, orientated and tranquil; Score 3: Responding to commands; Score 4: Brisk response to stimulus; Score 5: Sluggish response to stimulus; Score 6: No response to stimulus	During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered	No