The Effect of Lidocaine on Smooth Emergence With Double Lumen Tube

NCT04455711 | Unknown

• 1 other identifier: AJIRB-MED-OBS-16-342
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cough incidence

  from the time of end of the operation up to 10 min after extubation

Secondary Outcomes (2)

• Cough severity

  from the time of end of the operation up to 10 min after extubation

• hoarseness

  30 min at the recovery room

Study Arms (2)

Remifentanil group

PLACEBO COMPARATOR

Emerge with continuous infusion of remifentanil 1.5 ng/ml

Drug: Remifentanil

Lidocaine group

EXPERIMENTAL

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

Drug: Lidocaine Iv; Drug: Remifentanil

Interventions

Lidocaine Iv DRUG

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

Lidocaine group

Remifentanil DRUG

Continuous infusion of remifentanil 1.5 ng/ml until extubation

Lidocaine group; Remifentanil group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Location

MeSH Terms

Conditions

Cough

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ji young Yoo

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji young Yoo, assistant professor

CONTACT

82-31-219-5577; springbear@nate.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: July 2, 2020
• Study Start: July 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)