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Effect of Intra-Cuff Lidocaine and Tetracaine on Tracheal Tube-Induced Emergence Phenomena
This study is currently recruiting participants.
Verified by Sichuan University, October 2008
Sponsored by: Sichuan University
Information provided by: Sichuan University
ClinicalTrials.gov Identifier: NCT00798018
  Purpose

It has been proven that tracheal tube inflated with lidocaine could decrease the post-intubation sore throat in nitrous oxide anesthesia. In the investigators 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.


Condition Intervention
Pharyngitis
Drug: lidocaine and tetracaine

MedlinePlus related topics: Anesthesia Sore Throat
Drug Information available for: Tetracaine Viractin Lidocaine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
Official Title: Effect of Intra-Cuff Lidocaine and Tetracaine on Tracheal Tube-Induced Emergence Phenomena

Further study details as provided by Sichuan University:

Primary Outcome Measures:
  • visual analogue scale(0-100mm) by the subject. [ Time Frame: 6h,24h,48h after extubation ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lidocaine and tetracaine
    lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume
Detailed Description:

The patients 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 xtubation. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients of the age group 18-60 years 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) were included in the study.

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, were excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798018

Contacts
Contact: Han Huang, M.D +86-0-13880259785 huanghan1981@hotmail.com

Locations
China, Sichuan
Department of Anesthesiology, West China Second Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Wei Huang, M.D     +86-28-85503752        
Principal Investigator: Han Huang, M.D            
Sponsors and Collaborators
Sichuan University
Investigators
Principal Investigator: Han Huang, M.D Department of Aensthesiology, West China 2nd Hospital, Sichuan University
  More Information

Publications:
Responsible Party: Department of Anesthesiology, West China Second Hospital ( Dr. )
Study ID Numbers: ICLT
Study First Received: November 24, 2008
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00798018  
Health Authority: China: Ethics Committee

Keywords provided by Sichuan University:
lidocaine
tetracaine
tracheal intubation
pharyngitis

Study placed in the following topic categories:
Tetracaine
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lidocaine
Stomatognathic Diseases
Pharyngitis
Pharyngeal Diseases

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009