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

NCT00798018 | Completed Results

• 1 other identifier: ICLT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharyngitis

Keywords

lidocaine; tetracaine; tracheal intubation; pharyngitis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 hours, 12 hours, 24 hours, 48 hours after extubation

Study Arms (4)

Air

PLACEBO COMPARATOR

air was used to inflate the cuff.

Drug: placebo

Normal Saline

PLACEBO COMPARATOR

Normal saline was used to inflate the cuff.

Drug: N.S

lidocaine

ACTIVE COMPARATOR

2% lidocaine was used to inflate the cuff.

Drug: 2% lidocaine

tetracaine

EXPERIMENTAL

1% tetracaine was used to inflate the cuff.

Drug: 1% tetracaine

Interventions

2% lidocaine DRUG

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

lidocaine

placebo DRUG

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

Air

1% tetracaine DRUG

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

tetracaine

N.S DRUG

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

Normal Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

Department of Anesthesiology, West China Second Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• 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.

  PMID: 14970135 BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Interventions

Lidocaine; Tetracaine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Han Huang
• Organization: Department of Anesthesiology, West China Second Hospital

huanghan1981@hotmail.com

80-028-8550-3753

Study Officials

• Han Huang, M.D

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 18, 2009
• Results First Posted: December 18, 2009

Record last verified: 2009-11

Locations

CN (1)