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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03218124
Date of registration: 10/07/2017
Prospective Registration: Yes
Primary sponsor: University of Cagliari
Public title: Optimal Remifentanil Concentration and Thyroidectomy ORCO
Scientific title: Optimal Effect Site Remifentanil Concentration for Smooth Extubation After Thyroid Surgery
Date of first enrolment: October 1, 2017
Target sample size: 30
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT03218124
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Italy
Contacts
Name:     Paolo Onida, MD
Address: 
Telephone: +39 07051096543
Email: paolo.onida80@gmail.com
Affiliation: 
Name:     Gabriele Finco, MD
Address: 
Telephone:
Email:
Affiliation:  Cagliari University
Key inclusion & exclusion criteria

Inclusion Criteria:

- 18
- 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



Age minimum: 18 Years
Age maximum: 67 Years
Gender: All
Health Condition(s) or Problem(s) studied
Anesthesia
Intervention(s)
Other: Remifentanil Effect site concentration
Primary Outcome(s)
Cough [Time Frame: 15 minutes after surgery]
Secondary Outcome(s)
Hemodynamics 1 [Time Frame: 15 minutes after surgery]
Hemodynamics 2 [Time Frame: 15 minutes after surgery]
Respiratory outcome 1 [Time Frame: 15 minutes after surgery]
Respiratory outcome 2 [Time Frame: 15 minutes after surgery]
Secondary ID(s)
Remismooth2217
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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