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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

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


Condition or disease Intervention/treatment Phase
Cough Drug: Extubation U Drug: Extubation T Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : January 2011
Actual Primary Completion Date : January 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Active Comparator: Extubation U
Remifentanil concentration between 2 - 3 ng/ml.
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

Experimental: Extubation T
Remifentanil concentration between 3 - 4 ng/ml
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711904


Locations
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Colombia
Instituto Para Niños Ciegos y Sordos del Valle del Cauca
Santiago de Cali, Valle del Cauca, Colombia, 288 00
Sponsors and Collaborators
Seganest
Instituto Para Ninos Ciegos y Sordos del Valle del Cauca
Investigators
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Principal Investigator: LUIS A TAFUR, MD Seganest
Study Director: Eduardo Lema, MD Seganest

Publications:
Tafur LA, Gómez JM, Parra LE. Validación de nomogramas de remifentanil y propofol para la administración de anestesia total endovenosa. Rev. Col. Anest. 2009; 37:21-8.
Dennis R. Cómo estimar el tamaño de la muestra en investigación con humanos. Acta Méd Colom. 1989;14: 92-99.
Dobson AJ. Calculating simple size. Transactions of the Menzie Foundation. 1984; 7:75-79.
Coleridge HM, Coleridge JCC. Reflexes evoked from the tracheobronchial tree and lungs. In: Handbook of Physiology, Section 3: the Respiratory System, Vol II: Control of Breathing, Part I (Cherniack NS, Widdicombe JG, eds). Washington, DC:American Physiological Society, 1986;395-429.
Widdicombe JG. Vagal reflexes in the airways. In: Neural Regulation of the Airways in Health and Disease (Kaliner M, Barnes PJ, eds). New York:Marcel Dekker, 1988;187-202.

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Responsible Party: LUIS ALBERTO TAFUR B, Principal Investigator, Seganest
ClinicalTrials.gov Identifier: NCT02711904    
Other Study ID Numbers: SEGANEST
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual data of the participants (IPD) were only available to the ethics committee of the institution.
Keywords provided by LUIS ALBERTO TAFUR B, Seganest:
Extubation
Cough
Target Controlled Anesthesia (TACAN)
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents