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Completed

NCT Number: NCT02528825

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.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jiyoung Yoo

Suweon, Kyunggido, 443-380, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remifentanil titration

Drug

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.

Primary outcomes

  1. Smooth emergence success or fail

    Time frame: from the time of remifentanil equivalent state( postop 5 minute) to extubation

    smooth emergence is success

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2015
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.