Optimal Remifentanil Concentration and Thyroidectomy

Overview

The study is aimed at determining the remifentanil effect site concentration suppressing the cough at extubation after surgical thyroidectomy, performed under remifentanil/desflurane based general anesthesia, expressed as median and 95th percentile effective dose. Possible hemodynamic instability, respiratory depression or prolongation of awakening time are also sought.

Full Title of Study: “Optimal Effect Site Remifentanil Concentration for Smooth Extubation After Thyroid Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2018

Interventions

  • Other: Remifentanil Effect site concentration
    • After skin suture, a predetermined Effect site remifentanil concentration will be achieved. Starting from 1.5 ng/ml in the first patient and increased or decreased by 0.2 ng/ml intervals based on the previous patient response: up if cough present, down otherwise (“Dixon’s up and down” method).

Arms, Groups and Cohorts

  • Experimental: remifentanil
    • After skin suture, a predetermined Effect site remifentanil concentration will be achieved. Starting from 1.5 ng/ml in the first patient and increased or decreased by 0.2 ng/ml intervals based on the previous patient response: up if cough present, down otherwise (“Dixon’s up and down” method).

Clinical Trial Outcome Measures

Primary Measures

  • Cough
    • Time Frame: 15 minutes after surgery
    • Any episode of sudden and violent abdominal contraction interrupting normal quite spontaneous or assisted ventilation would be accounted as “cough” and defines non-smooth extubation

Secondary Measures

  • Hemodynamics 1
    • Time Frame: 15 minutes after surgery
    • Heart Rate (bpm)
  • Hemodynamics 2
    • Time Frame: 15 minutes after surgery
    • Blood pressure (mmHg)
  • Respiratory outcome 1
    • Time Frame: 15 minutes after surgery
    • Tidal Volume (ml)
  • Respiratory outcome 2
    • Time Frame: 15 minutes after surgery
    • End Tidal Carbon Dioxide (mmHg)

Participating in This Clinical Trial

Inclusion Criteria

  • 18<age<67 – 6 hrs fasting – American society of anesthesiology (ASA) Physical Status I o II – Informed consent Exclusion Criteria:

  • Absence of inclusion criteria – Use of cough suppressors, angiotensin converting enzyme-inhibitors, sedatives 4 weeks before surgery – Arhythmia, pacemaker or unstable cardiovascular disease – Hepatic or renal failure – Anticipated difficulty in airways management – Chronic obstructive pulmonary disease (COPD), Asthma, increased risk for inhalation, airway infection in the previous 4 weeks; – Smoker – Obesity (BMI >35) – Pregnancy – Hypersensitivity to drugs administered for the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 67 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Cagliari
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Gabriele Finco, Professor of Anesthesiology and Intensive Care – University of Cagliari
  • Overall Official(s)
    • Gabriele Finco, MD, Principal Investigator, Cagliari University
  • Overall Contact(s)
    • Paolo Onida, MD, +39 07051096543, paolo.onida80@gmail.com

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