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

Primary Purpose

Pharyngitis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
2% lidocaine
placebo
1% tetracaine
N.S
Sponsored by
Sichuan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pharyngitis focused on measuring lidocaine, tetracaine, tracheal intubation, pharyngitis

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology, West China Second Hospital, Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Experimental

Arm Label

Air

Normal Saline

lidocaine

tetracaine

Arm Description

air was used to inflate the cuff.

Normal saline was used to inflate the cuff.

2% lidocaine was used to inflate the cuff.

1% tetracaine was used to inflate the cuff.

Outcomes

Primary Outcome Measures

Visual Analogue Scale(0-100mm) by the Subject.
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.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2008
Last Updated
December 17, 2009
Sponsor
Sichuan University
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1. Study Identification

Unique Protocol Identification Number
NCT00798018
Brief Title
Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena
Official Title
Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sichuan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis
Keywords
lidocaine, tetracaine, tracheal intubation, pharyngitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Air
Arm Type
Placebo Comparator
Arm Description
air was used to inflate the cuff.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Normal saline was used to inflate the cuff.
Arm Title
lidocaine
Arm Type
Active Comparator
Arm Description
2% lidocaine was used to inflate the cuff.
Arm Title
tetracaine
Arm Type
Experimental
Arm Description
1% tetracaine was used to inflate the cuff.
Intervention Type
Drug
Intervention Name(s)
2% lidocaine
Intervention Description
lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Air injected into the cuff to seal the space between the trachea and the tube at minimal volume
Intervention Type
Drug
Intervention Name(s)
1% tetracaine
Intervention Description
tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume
Intervention Type
Drug
Intervention Name(s)
N.S
Intervention Description
0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume
Primary Outcome Measure Information:
Title
Visual Analogue Scale(0-100mm) by the Subject.
Description
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.
Time Frame
6 hours, 12 hours, 24 hours, 48 hours after extubation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Huang, M.D
Organizational Affiliation
Department of Aensthesiology, West China 2nd Hospital, Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, West China Second Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
14970135
Citation
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.
Results Reference
background

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

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