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Optimal Remifentanil Concentration and Thyroidectomy (ORCO)

U

University of Cagliari

Status

Unknown

Conditions

Anesthesia

Treatments

Other: Remifentanil Effect site concentration

Study type

Interventional

Funder types

Other

Identifiers

NCT03218124
Remismooth2217

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 67 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

remifentanil
Experimental group
Description:
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).
Treatment:
Other: Remifentanil Effect site concentration

Trial contacts and locations

1

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Central trial contact

Paolo Mura, MD; Paolo Onida, MD

Data sourced from clinicaltrials.gov

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