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The Effect of Lidocaine on Smooth Emergence With Double Lumen Tube

Primary Purpose

Cough, Lidocaine

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lidocaine Iv
Remifentanil
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cough

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Remifentanil group

Lidocaine group

Arm Description

Emerge with continuous infusion of remifentanil 1.5 ng/ml

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

Outcomes

Primary Outcome Measures

Cough incidence

Secondary Outcome Measures

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)
hoarseness

Full Information

First Posted
May 6, 2020
Last Updated
June 29, 2020
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04455711
Brief Title
The Effect of Lidocaine on Smooth Emergence With Double Lumen Tube
Official Title
The Efficacy of Intravenous Lidocaine With Continuous Infusion of Remifentanil for Attenuating Double Lumen Tube Induced Cough During Emergence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Lidocaine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remifentanil group
Arm Type
Placebo Comparator
Arm Description
Emerge with continuous infusion of remifentanil 1.5 ng/ml
Arm Title
Lidocaine group
Arm Type
Experimental
Arm Description
Emerge with continuous infusion of remifentanil 1.5 ng/ml with IV bolus of lidocaine 1.5 mg/kg
Intervention Type
Drug
Intervention Name(s)
Lidocaine Iv
Intervention Description
Bolus dose of 1.5 mg/kg lidocaine was injected immediate after operation.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Continuous infusion of remifentanil 1.5 ng/ml until extubation
Primary Outcome Measure Information:
Title
Cough incidence
Time Frame
from the time of end of the operation up to 10 min after extubation
Secondary Outcome Measure Information:
Title
Cough severity
Description
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)
Time Frame
from the time of end of the operation up to 10 min after extubation
Title
hoarseness
Time Frame
30 min at the recovery room

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji young Yoo, assistant professor
Phone
82-31-219-5577
Email
springbear@nate.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji young Yoo
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggido
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiyoung Yoo, assistant professor
Phone
031-219-5577

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Lidocaine on Smooth Emergence With Double Lumen Tube

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