The Effect of Lidocaine on Smooth Emergence With Double Lumen Tube

Cough Clinical Trial

Official title:

The Efficacy of Intravenous Lidocaine With Continuous Infusion of Remifentanil for Attenuating Double Lumen Tube Induced Cough During Emergence

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04455711
• Other study ID #: AJIRB-MED-OBS-16-342
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: June 2020
• Source: Ajou University School of Medicine
• Contact: Ji young Yoo, assistant professor
• Phone: 82-31-219-5577
• Email: springbear[@]nate.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Lidocaine

Intervention

Drug:
• Lidocaine Iv
Bolus dose of 1.5 mg/kg lidocaine was injected immediate after operation.
• Remifentanil
Continuous infusion of remifentanil 1.5 ng/ml until extubation

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough incidence		from the time of end of the operation up to 10 min after extubation
Secondary	Cough severity	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)	from the time of end of the operation up to 10 min after extubation
Secondary	hoarseness		30 min at the recovery room