Comparison of Effectiveness Between the Combination of Lidocaine Sprayed at Laryngeal Inlet and on the Cuff of Endotracheal Tube Versus Intravenous Lidocaine for Reducing Cough During Extubation

NCT ID: NCT04090112

Last Updated: 2019-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Coughing during extubation of endotracheal tube (ETT) is a common problem that leads to poor surgical results including hemodynamic change, rebleeding at the surgical wound and wound dehiscence. Recently, lidocaine has been introduced for reducing coughing during extubation. However, data comparing routes of lidocaine application are lacking, thus, this study compared the combination of lidocaine sprayed on laryngeal inlet and cuff of ETT versus intravenous lidocaine injection for efficacy in reducing coughing

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A prospective randomized control trial was conduct with 164 patients. They were randomly allocated into Gr. A and B. Group A received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet whereas Gr. B received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation. The same general anesthesia protocol was applied in all of the patients. Incidence and severity of cough during extubation was evaluated. Furthermore, incidence of 24-hour postoperative adverse events (including sore throat, dysphagia, and hoarseness) and hemodynamic response after extubation were analyzed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Reducing Cough During Extubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The randomized controled trial was conducted. the investigator allocated patient into two arms. Group A received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet whereas Gr. B received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The study based on a sequentially numbered list were prepared in the same way. Participant and outcome assessor were blined to the computer generated lists

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

the study group (Group A)

Patients received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet

Group Type EXPERIMENTAL

10% lidocaine sprayed

Intervention Type DRUG

four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet

Comparator group (Group B)

Patients received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation

Group Type ACTIVE_COMPARATOR

2% lidocaine intravenous

Intervention Type DRUG

15 mg/kg of 2% lidocaine intravenous injection prior to extubation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

10% lidocaine sprayed

four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet

Intervention Type DRUG

2% lidocaine intravenous

15 mg/kg of 2% lidocaine intravenous injection prior to extubation

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

10% Xylociane 2% Xylocaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients who underwent elective surgery with American Society of Anesthesiologists physical status classifications of I and III

Exclusion Criteria

* patients having body mass index more than 35 kg/m2, high risk of aspiration, chronic smokers more than ten pack-years, chronic cough or recent upper respiratory infection, suspected difficult airway, retained ETT prior surgery, surgery at oral cavity, neck and thoracic region, operative time more than 120 minutes or less than 30 minutes, and history of lidocaine allergy
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pornthep Kasemsiri

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

PORNTHEP KASEMSIRI

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Khon Kaen University

Khon Kaen, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

D'Aragon F, Beaudet N, Gagnon V, Martin R, Sansoucy Y. The effects of lidocaine spray and intracuff alkalinized lidocaine on the occurrence of cough at extubation: a double-blind randomized controlled trial. Can J Anaesth. 2013 Apr;60(4):370-6. doi: 10.1007/s12630-013-9896-8. Epub 2013 Feb 1.

Reference Type RESULT
PMID: 23370978 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HE611394

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.