Optimal Remifentanil Concentration and Thyroidectomy (ORCO)

Optimal Effect Site Remifentanil Concentration for Smooth Extubation After Thyroid Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Other: Remifentanil Effect site concentration

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Cagliari
    • Monserrato, Cagliari, Italy, 09072
      • Policlinico Duilio Casula

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remifentanil; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Cagliari
• Investigators: Principal Investigator: Gabriele Finco, MD, Cagliari University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Remifentanil; Cough; Target controlled infusion; Thyroidectomy; Extubation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: Remismooth2217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No