Optimal Remifentanil Concentration and Thyroidectomy

NCT03218124 | Unknown

• 1 other identifier: Remismooth2217
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Thyroidectomy; Remifentanil; Extubation; Cough; Target controlled infusion

Outcome Measures

Primary Outcomes (1)

• Cough

  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

  15 minutes after surgery

Secondary Outcomes (4)

• 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

Study Arms (1)

remifentanil

EXPERIMENTAL

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).

Other: Remifentanil Effect site concentration

Interventions

Remifentanil Effect site concentration OTHER

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).

remifentanil

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<age\<67
• hrs fasting
• American society of anesthesiology (ASA) Physical Status I o II
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

Policlinico Duilio Casula

Monserrato, Cagliari, 09072, Italy

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

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

Study Officials

• Gabriele Finco, MD

  Cagliari University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Onida, MD

CONTACT

+39 07051096543; paolo.onida80@gmail.com

Paolo Mura, MD

CONTACT

+39 07051096543; mura_paolo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patient under general anesthesia unaware of the effect site concentration of remifentanil before extubation
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Intensive Care

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

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 14, 2017
• Study Start: October 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 14, 2017

Record last verified: 2017-07

Locations

IT (1)