Concentrations of Remifentanil for Extubation

NCT02711904 | Completed Phase 4 DMC

• 1 other identifier: SEGANEST
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Cough

Keywords

Extubation; Cough; Target Controlled Anesthesia (TACAN)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Wake time.

  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.

• Ramsay scale at the time of extubation

  During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered

Study Arms (2)

Extubation U

ACTIVE COMPARATOR

Remifentanil concentration between 2 - 3 ng/ml.

Drug: Extubation U

Extubation T

EXPERIMENTAL

Remifentanil concentration between 3 - 4 ng/ml

Drug: Extubation T

Interventions

Extubation U DRUG

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.

Also known as: Ultiva

Extubation U

Extubation T DRUG

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.

Also known as: Ultiva

Extubation T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged 18-70 years
• Risk Scale American Society of Anaesthesiologists physical status classification (ASA) I and II
• Undergoing elective ear surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Seganest: lead
• Instituto Para Ninos Ciegos y Sordos del Valle del Cauca: collaborator

Study Sites (1)

Instituto Para Niños Ciegos y Sordos del Valle del Cauca

Cali, Valle del Cauca Department, 288 00, Colombia

Location

Related Publications (33)

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MeSH Terms

Conditions

Cough

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• LUIS A TAFUR, MD

  Seganest

  PRINCIPAL INVESTIGATOR

• Eduardo Lema, MD

  Seganest

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: March 17, 2016
• Study Start: January 1, 2011
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2012
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)