MedDataX Logo

Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena

NCT ID: NCT00798018

Last Updated: 2009-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-02-28

Brief Summary

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

It has been proven that tracheal tube inflated with lidocaine could decrease the post-intubation sore throat in nitrous oxide anesthesia. In the study, the investigators would like to evaluate the effect of lidocaine inflation in non-nitrous oxide anesthesia and compare the effect of tetracaine, the best mucosal local anesthetics with lidocaine.

Detailed Description

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

The female patients receiving gynecological surgeries were divided into air, saline and 2% lidocaine and 1% tetracaine groups of 25 each using sealed envelope technique. The cuff of the endotracheal tube was inflated by the inflation medium (with the help of intracuff pressure monitoring device) to occlude the leak around the tube by the Minimal Occlusive Volume Technique. This was done by the same anaesthesiologist in all the patients. The cuff volume and pressure were then recorded. The primary outcome of the study was to evaluate the post-intubation sore throat using the visual analogue scale 6h, 24h and 48h after extubation. The secondary outcomes were incidence of complications during emergence of anesthesia and after extubation. Intra-cuff pressure monitoring was done with a pressure monitor, which consisted of the pressure gauge, three-way stopcock whose one end was attached to the pressure monitoring line. Net volume of the inflation medium was noted. Volume of the inflation medium, intra cuff pressure, duration from intubation to extubation and volume of the inflation medium withdrawn from the cuff was noted. Incidence (Yes/No) of tube intolerance, coughing on tube, restlessness, hoarseness, sore throat, breathlessness and laryngospasm were analyzed by the anaesthesiologist who did not know which group the patient belonged to.

Conditions

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

Pharyngitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

lidocaine tetracaine tracheal intubation pharyngitis

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

Air

air was used to inflate the cuff.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Air injected into the cuff to seal the space between the trachea and the tube at minimal volume

Normal Saline

Normal saline was used to inflate the cuff.

Group Type PLACEBO_COMPARATOR

N.S

Intervention Type DRUG

0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume

lidocaine

2% lidocaine was used to inflate the cuff.

Group Type ACTIVE_COMPARATOR

2% lidocaine

Intervention Type DRUG

lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume

tetracaine

1% tetracaine was used to inflate the cuff.

Group Type EXPERIMENTAL

1% tetracaine

Intervention Type DRUG

tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume

Interventions

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

2% lidocaine

lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume

Intervention Type DRUG

placebo

Air injected into the cuff to seal the space between the trachea and the tube at minimal volume

Intervention Type DRUG

1% tetracaine

tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume

Intervention Type DRUG

N.S

0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* patients of the age group 18-60 years
* patients belonging to ASA grade I and II undergoing gynecological surgeries in supine position under general anesthesia with controlled ventilation using Poly Vinyl Chloride ETT (same type and make in all patients)

Exclusion Criteria

* anticipated difficult intubation
* more than one attempt for intubation
* need for naso gastric tube
* episode of coughing and straining
* history of respiratory tract infection and smoking
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

Sichuan University

OTHER

Sponsor Role lead

Responsible Party

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

Department of Anesthesiology, West China Second Hospital

Principal Investigators

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

Han Huang, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Aensthesiology, West China 2nd Hospital, Sichuan University

Locations

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

Department of Anesthesiology, West China Second Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

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

China

References

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

Estebe JP, Delahaye S, Le Corre P, Dollo G, Le Naoures A, Chevanne F, Ecoffey C. Alkalinization of intra-cuff lidocaine and use of gel lubrication protect against tracheal tube-induced emergence phenomena. Br J Anaesth. 2004 Mar;92(3):361-6. doi: 10.1093/bja/aeh078.

Reference Type BACKGROUND
PMID: 14970135 (View on PubMed)

Other Identifiers

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

ICLT

Identifier Type: -

Identifier Source: org_study_id