The Effect of Lidocaine on Smooth Emergence With Double Lumen Tube

NCT ID: NCT04455711

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-07-31

Brief Summary

Cough suppression during emergence and tracheal extubation from general anaesthesia has become an important issue as part of patient safety. Cough arised from the mechanical irritation of endotracheal tube and cuff could be accompanied by various adverse effects such as laryngospasm, hypertension, tachycardia, arrhythmia and increase of intracranial, intraocular, or intra-abdominal pressure.

Several cough-preventing strategies have been proposed for smooth emergence, such as opioids, dexmedetomidine or lidocaine. Maintenance of remifentanil infusion during emergence has been reported to be an effective method in reducing cough and cardiovascular change without delay of recovery. In previous studies, the effetive effect-site concentraions for 95% of adults (EC95) for preventing cough are a little different depending on anaestheic agent, type of surgery and sex, ranged from 2.14 to 2.94 ng/ml. However, since most of these studies are for sing lumen endotracheal tube, similar preventing effect would not be expected for double lumen tube (DLT) because of its large diameter and long length. Another problem is higher concentration of remifentanil more than 2.5 ng/ml could not guarantee the safety after extubation. The efficacy of a single IV bolus of lidocaine for the prevention of cough has been the subject of numerous trials.

Therefore, combined use of lidocaine and remifentanil could effectively prevent emergence cough for DLT without the risk of high concentration of remifentanil.

Conditions

Cough; Lidocaine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Remifentanil group

Emerge with continuous infusion of remifentanil 1.5 ng/ml

Group Type: PLACEBO_COMPARATOR

Remifentanil

Intervention Type: DRUG

Continuous infusion of remifentanil 1.5 ng/ml until extubation

Lidocaine group

Emerge with continuous infusion of remifentanil 1.5 ng/ml with IV bolus of lidocaine 1.5 mg/kg

Group Type: EXPERIMENTAL

Lidocaine Iv

Intervention Type: DRUG

Bolus dose of 1.5 mg/kg lidocaine was injected immediate after operation.

Remifentanil

Intervention Type: DRUG

Continuous infusion of remifentanil 1.5 ng/ml until extubation

Interventions

Lidocaine Iv

Bolus dose of 1.5 mg/kg lidocaine was injected immediate after operation.

Intervention Type: DRUG

Remifentanil

Continuous infusion of remifentanil 1.5 ng/ml until extubation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients needs for double lumen tube intubation for one lung ventilation during surgery with ASA (American society of Anesthesiologists) class I or II

Exclusion Criteria

• Gastroesophageal reflux disease
• Obese patients (BMI > 30)
• Recent upper respiratory infection history (within 3 weeks)
• Asthma history
• Anticipating difficult airway

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jiyoung Yoo

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ji young Yoo

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Countries

South Korea

Central Contacts

Ji young Yoo, assistant professor

Role: CONTACT

springbear@nate.com

82-31-219-5577

Facility Contacts

Jiyoung Yoo, assistant professor

Role: primary

031-219-5577

Other Identifiers

AJIRB-MED-OBS-16-342

Identifier Type: -

Identifier Source: org_study_id