Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Concentrations of Remifentanil for Extubation (REMEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02711904
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : March 17, 2016
Sponsor:
Collaborator:
Instituto Para Ninos Ciegos y Sordos del Valle del Cauca
Information provided by (Responsible Party):
LUIS ALBERTO TAFUR B, Seganest

Tracking Information
First Submitted Date  ICMJE August 27, 2013
First Posted Date  ICMJE March 17, 2016
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
Cough [ Time Frame: 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 ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • Wake time. [ Time Frame: 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. ]
    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.
  • Ramsay scale at the time of extubation [ Time Frame: During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concentrations of Remifentanil for Extubation
Official Title  ICMJE Effect of Two Plasma Concentrations of Remifentanil Through Target Controlled Anesthesia on Frequency and Intensity of Coughing During Extubation: Randomized Controlled Clinical Trial
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cough
Intervention  ICMJE
  • 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.
    Other Name: Ultiva
  • 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.
    Other Name: Ultiva
Study Arms  ICMJE
  • Active Comparator: Extubation U
    Remifentanil concentration between 2 - 3 ng/ml.
    Intervention: Drug: Extubation U
  • Experimental: Extubation T
    Remifentanil concentration between 3 - 4 ng/ml
    Intervention: Drug: Extubation T
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2016)
110
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02711904
Other Study ID Numbers  ICMJE SEGANEST
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The individual data of the participants (IPD) were only available to the ethics committee of the institution.
Responsible Party LUIS ALBERTO TAFUR B, Seganest
Study Sponsor  ICMJE Seganest
Collaborators  ICMJE Instituto Para Ninos Ciegos y Sordos del Valle del Cauca
Investigators  ICMJE
Principal Investigator: LUIS A TAFUR, MD Seganest
Study Director: Eduardo Lema, MD Seganest
PRS Account Seganest
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP