Optimal Effect Site Remifentanil Concentration for Smooth Extubation After Thyroid Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Cagliari
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Cough
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
Patient under general anesthesia unaware of the effect site concentration of remifentanil before extubation
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •Obesity (BMI >35)
- •Pregnancy
- •Hypersensitivity to drugs administered for the study
Arms & Interventions
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).
Intervention: Remifentanil Effect site concentration (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Hemodynamics 1(15 minutes after surgery)
- Hemodynamics 2(15 minutes after surgery)
- Respiratory outcome 1(15 minutes after surgery)
- Respiratory outcome 2(15 minutes after surgery)
Investigators
Prof. Gabriele Finco
Professor of Anesthesiology and Intensive Care
University of Cagliari