Optimal Remifentanil Concentration and Thyroidectomy

Not Applicable

• Conditions: Anesthesia
• Interventions: Other: Remifentanil Effect site concentration

• Registration Number: NCT03218124
• Lead Sponsor: University of Cagliari

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Study First Posted: 2017-07-14
• Last Update Posted: 2017-07-14
• Study Start: 2017-10-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
remifentanil	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).

Primary Outcome Measures

Name	Time	Method
Cough	15 minutes after surgery	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

Secondary Outcome Measures

Name	Time	Method
Hemodynamics 1	15 minutes after surgery	Heart Rate (bpm)
Hemodynamics 2	15 minutes after surgery	Blood pressure (mmHg)
Respiratory outcome 1	15 minutes after surgery	Tidal Volume (ml)
Respiratory outcome 2	15 minutes after surgery	End Tidal Carbon Dioxide (mmHg)

Trial Locations

Locations (1)

Policlinico Duilio Casula; 🇮🇹 Monserrato, Cagliari, Italy