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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00798018
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : December 18, 2009
Last Update Posted : December 18, 2009
Sponsor:
Information provided by:
Sichuan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pharyngitis Drug: 2% lidocaine Drug: placebo Drug: 1% tetracaine Drug: N.S Not Applicable

Detailed Description:
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of the inflation medium, intra cuff pressure, duration from intubation to extubation and volume of the inflation medium withdrawn from the cuff was noted.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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena
Study Start Date : October 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Placebo Comparator: Air
air was used to inflate the cuff.
Drug: placebo
Air injected into the cuff to seal the space between the trachea and the tube at minimal volume

Placebo Comparator: Normal Saline
Normal saline was used to inflate the cuff.
Drug: N.S
0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume

Active Comparator: lidocaine
2% lidocaine was used to inflate the cuff.
Drug: 2% lidocaine
lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume

Experimental: tetracaine
1% tetracaine was used to inflate the cuff.
Drug: 1% tetracaine
tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume




Primary Outcome Measures :
  1. Visual Analogue Scale(0-100mm) by the Subject. [ Time Frame: 6 hours, 12 hours, 24 hours, 48 hours after extubation ]
    visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798018


Locations
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China, Sichuan
Department of Anesthesiology, West China Second Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Sichuan University
Investigators
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Principal Investigator: Han Huang, M.D Department of Aensthesiology, West China 2nd Hospital, Sichuan University
Publications:
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Responsible Party: Dr., Department of Anesthesiology, West China Second Hospital
ClinicalTrials.gov Identifier: NCT00798018    
Other Study ID Numbers: ICLT
First Posted: November 25, 2008    Key Record Dates
Results First Posted: December 18, 2009
Last Update Posted: December 18, 2009
Last Verified: November 2009
Keywords provided by Sichuan University:
lidocaine
tetracaine
tracheal intubation
pharyngitis
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action