Optimal Remifentanil Ce for Preventing Severe Cough and Hyperdynamic Response During Tracheal Extubation

NCT03132519 | Completed Phase 4 DMC

• 1 other identifier: REX
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief Summary

Pain, cough, hypertension and tachycardia are frequent events during extubation due to a secondary stimulation of mechanoreceptors located in the airway. The mechanical effect of the endotracheal tube activates autonomic reflexes, a situation that could potentially impair the clinical condition of patients. Previous studies have used remifentanil during emergence and extubation showing good results to control this reflex response. However, it is unknown so far, the optimal effect site concentration (Ce) of remifentanil to allow a better control of these events with a low incidence of adverse effects after have received inhaled anesthesia plus remifentanil for anesthetic maintenance. This study will determine the Ce of remifentanil associated with a lower proportion of cough and hyperdynamic circulatory response during extubation for emergency after exposure to sevoflurane or desflurane.

Conditions

Cough; Hypertension

Keywords

Cough; Hypertension; Remifentanil; Sevoflurane; Desflurane

Outcome Measures

Primary Outcomes (1)

• Cough during emergency from anesthesia

  Assess the presence and intensity of cough : 0) No cough, 1) A single episode of cough, 2) More than one episode of nonsustained cough, 3) sustained and repetitive cough with head elevation.

  From eye opening up to 2.5 minutes after tracheal extubation

Secondary Outcomes (9)

• Cardiac response during emergence from anesthesia

  From discontinuation of inhalational anesthetics up to 2.5 minutes after tracheal extubation

• Pressor response during emergence from anesthesia

  From discontinuation of inhalational anesthetics up to 2.5 minutes post-extubation

• Time to eye opening

  From inhaled anesthetic discontinuation until the moment of eye opening response to verbal command (calling by name), assessed up to 20 minutes.

• Time to tracheal extubation

  From inhaled anesthetic discontinuation until the event of tracheal extubation, assessed up to 20 minutes.

• Halogenated end tidal concentration at tracheal extubation

  From eyes opening until the event of tracheal extubation, assessed up to 20 minutes.

Study Arms (6)

Sevo-2.0

EXPERIMENTAL

This group will maintain remifentanil infusion by TCI to 2 ng/ml during emergence and extubation after have received sevoflurane during procedure.

Drug: Remifentanil

Sevo-2.5

EXPERIMENTAL

This group will maintain the remifentanil infusion by TCI to 2.5 ng/ml during emergence and tracheal extubation after have received sevoflurane during surgical procedure.

Drug: Remifentanil

Des-2.0

EXPERIMENTAL

This group will maintain the remifentanil infusion by TCI to 2.0 ng/ml during emergence and tracheal extubation after have received desflurane during surgical procedure.

Drug: Remifentanil

Des-2.5

EXPERIMENTAL

This group will maintain the remifentanil infusion by TCI to 2.5 ng/ml during emergence and tracheal extubation after have received desflurane during surgical procedure.

Drug: Remifentanil

Sevo-Control

ACTIVE COMPARATOR

This group will maintain the remifentanil infusion by TCI to 1.0 ng/ml during emergence and tracheal extubation after have received sevoflurane during surgical procedure.

Drug: Remifentanil

Des-Control

ACTIVE COMPARATOR

This group will maintain the remifentanil infusion by TCI to 1.0 ng/ml during emergence and tracheal extubation after have received desflurane during surgical procedure.

Drug: Remifentanil

Interventions

Remifentanil DRUG

To maintain remifentanil Ce at 1.0 (control) vs. 2.0 vs. 2.5 ng/ml by a TCI system during anesthesia emergence until tracheal extubation

Also known as: Ultiva

Des-2.0; Des-2.5; Des-Control; Sevo-2.0; Sevo-2.5; Sevo-Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesia status I and II
• Age between 18 to 60 years.
• Elective surgery.

You may not qualify if:

• Uncontrolled hypertension. (SBP\> 180 mmHg) at pre anesthesia area.
• Active or uncontrolled pulmonary disease.
• Signs or history of difficult airway.
• Recent respiratory infection.
• Train-of-four (TOF) index \<90% at the end of surgery.
• Patients who have received some form of pre oral medication.
• Body mass Index above 30 kg/m2.
• Concomitant use of epidural catheter.
• Urgent surgery.

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

Study Sites (1)

Fundacion Valle del Lili

Cali, Valle del Cauca Department, 76001000, Colombia

Location

MeSH Terms

Conditions

Cough; Hypertension

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fredy G Ariza, MD., MSc.

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

• Ivan F Quintero, MD

  Fundacion Clinica Valle del Lili

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 28, 2017
• Study Start: October 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

CO (1)