Effect-site Concentration of Remifentanil for Smooth Removal of the Double-lumen Endotracheal Tube

Smooth emergence is important for patient safety and satisfaction. Coughing during emergence is associated with detrimental effects like laryngospasm, sore throat, hoarseness, negative pressure pulmonary edema and bleeding at surgical site 1. Especially sore throat and hoarseness are most common complications after extubation 2,3 and closely related to patient satisfaction 4. Using double lumen tube (DLT) increase the incidence of hoarseness and airway injury than using single lumen tube for it has large size5,6. Various technique and drugs have been proposed for reducing coughing during extubation including smooth emergence 1,7-11 and this is closely correlate with reducing sore throat and hoarseness 12. One of the proposed technique, the use of short acting opioids are prefered13-15 because it can be maintained during emergence with less respiratory depression. Remifentanil is a potent short acting opioid and several studies choose remifentanil combined with other anesthetic agents 1,15,16. There is a study about the EC50 and EC95 of remifentanil in effect site Target controlled infusion(TCI) for preventing cough during emergence after thyroidectomy with propofol-remifentanil anesthesia 15 but no study about the proper dose of remifentanil for smooth DLT extubation.

The purpose of this study was to evaluate the EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during extubation of DLT in total TIVA with propofol and remifentanil.

Study Overview

• Status: Completed
• Conditions: Remifentanil Concentration for Smooth Emergence
• Intervention / Treatment: Drug: Remifentanil titration

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyunggido
    • Suweon, Kyunggido, Korea, Republic of, 443-380
      • Jiyoung Yoo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-II,
• Undergoing general anesthesia with DLT for lung wedge resection

Exclusion Criteria:

• Anticipated difficult airway
• Surgical duration of > 120 min,
• Patient with gastroesophageal reflux or asthma, chronic obstructive disease and upper respiratory infection were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: smooth emergence; ASA I-II, aged 19-65 years undergoing general anesthesia with DLT for lung wedge resection were enrolled in this study.After completing the surgery, the propofol infusion was stopped, and effect-site concentration of remifentanil was titrated to predetermined concentration ( initial concentration being 1.5ng/ml for the first patient).The predetermined concentration was maintained at least 10 min throughout emergence for the effect site concentration and plasma concentration can be expected stable. The smooth emergence was defined as extubation without cough-a strong and sudden contraction of the abdomen. The predetermined concentration was decreased by 0.5 ng/ml for the next patient if the patient did not cough during emergence and similarly, if the patient coughed anytime during emergence, it was considered failed smooth emergence and predetermined concentration was increased by 0.5 ng/ml.

Drug: Remifentanil titration; Initial concentration being 1.5ng/ml for the first patient The smooth emergence was defined as extubation without cough-a strong and sudden contraction of the abdomen. The predetermined concentration was decreased by 0.5 ng/ml for the next patient if the patient did not cough during emergence and similarly, if the patient coughed anytime during emergence, it was considered failed smooth emergence and predetermined concentration was increased by 0.5 ng/ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smooth emergence success or fail	smooth emergence is success	from the time of remifentanil equivalent state( postop 5 minute) to extubation

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Ji Young Yoo, md, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• 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: AJIRB-MED-CT4-14-295