Optimal Remifentanil Concentration and Thyroidectomy

Anesthesia Clinical Trial

— ORCO  

Official title:

Optimal Effect Site Remifentanil Concentration for Smooth Extubation After Thyroid Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03218124
• Other study ID #: Remismooth2217
• Status: Not yet recruiting
• Phase: N/A
• First received: July 10, 2017
• Last updated: July 12, 2017
• Start date: October 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: July 2017
• Source: University of Cagliari
• Contact: Paolo Onida, MD
• Phone: +39 07051096543
• Email: paolo.onida80[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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).

Locations

Country	Name	City	State
Italy	Policlinico Duilio Casula	Monserrato	Cagliari

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hemodynamics 1	Heart Rate (bpm)	15 minutes after surgery
Secondary	Hemodynamics 2	Blood pressure (mmHg)	15 minutes after surgery
Secondary	Respiratory outcome 1	Tidal Volume (ml)	15 minutes after surgery
Secondary	Respiratory outcome 2	End Tidal Carbon Dioxide (mmHg)	15 minutes after surgery