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Optimal Remifentanil Concentration and Thyroidectomy

Optimal Effect Site Remifentanil Concentration for Smooth Extubation After Thyroid Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03218124
Acronym
ORCO
Enrollment
30
Registered
2017-07-14
Start date
2017-10-01
Completion date
2018-07-01
Last updated
2017-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Thyroidectomy, Remifentanil, Extubation, Cough, Target controlled infusion

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.

Interventions

OTHERRemifentanil 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).

Sponsors

University of Cagliari
Lead SponsorOTHER

Study design

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

Intervention model description

Prospective observational study. Decreasing/increasing remifentanil effect site concentrations (Dixon's up and down model) to obtain cough-free extubation after thyroidectomy

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
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; * Smoker * Obesity (BMI \>35) * Pregnancy * Hypersensitivity to drugs administered for the study

Design outcomes

Primary

MeasureTime frameDescription
Cough15 minutes after surgeryAny 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

MeasureTime frameDescription
Hemodynamics 115 minutes after surgeryHeart Rate (bpm)
Hemodynamics 215 minutes after surgeryBlood pressure (mmHg)
Respiratory outcome 115 minutes after surgeryTidal Volume (ml)
Respiratory outcome 215 minutes after surgeryEnd Tidal Carbon Dioxide (mmHg)

Countries

Italy

Contacts

Primary ContactPaolo Onida, MD
paolo.onida80@gmail.com+39 07051096543
Backup ContactPaolo Mura, MD
mura_paolo@hotmail.com+39 07051096543

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026