The Effect of Lidocaine on Smooth Emergence With Double Lumen Tube

Not Applicable

• Conditions: Lidocaine; Cough
• Interventions: Drug: Lidocaine Iv; Drug: Remifentanil

• Registration Number: NCT04455711
• Lead Sponsor: Ajou University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-06
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-29
• Last Update Submitted: 2020-06-29
• Study Start: 2020-07-01
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	Lidocaine Iv	Emerge with continuous infusion of remifentanil 1.5 ng/ml with IV bolus of lidocaine 1.5 mg/kg
Lidocaine group	Remifentanil	Emerge with continuous infusion of remifentanil 1.5 ng/ml with IV bolus of lidocaine 1.5 mg/kg
Remifentanil group	Remifentanil	Emerge with continuous infusion of remifentanil 1.5 ng/ml

Primary Outcome Measures

Name	Time	Method
Cough incidence	from the time of end of the operation up to 10 min after extubation

Secondary Outcome Measures

Name	Time	Method
Cough severity	from the time of end of the operation up to 10 min after extubation	cough severity is graded as follows; mild cough (1 cough without lifting head), moderate cough ( more than 1 cough not sustained more than 5 seconds), severe cough (cough sustained more than 5 seconds)
hoarseness	30 min at the recovery room

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Gyeonggido, Korea, Republic of