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Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

NCT ID: NCT01774292

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of the study is to determined whether the administration of alkalized 4% lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence of coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous oxide as an anesthetic agent.

Detailed Description

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The diffusion of nitrous oxide inside the endotracheal cuff leads to increase pressure, pain and coughing. Studies have shown benefit of alkalized lidocaine and other mediums within the cuff with nitrous oxide. No study has yet evaluated the benefit of alkalized lidocaine in long surgeries without the use of nitrous oxide.

Conditions

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Coughing Extubation Lidocaine Endotracheal Cuff

Keywords

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Impact of alkalized lidocaine on coughing at extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Alkalized lidocaine

160 mg of 4% lidocaine (4 ml) in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.

Group Type ACTIVE_COMPARATOR

Endotracheal intubation with injection of liquid in the cuff

Intervention Type PROCEDURE

Sterile saline

4 mL of sterile saline in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.

Group Type PLACEBO_COMPARATOR

Endotracheal intubation with injection of liquid in the cuff

Intervention Type PROCEDURE

Interventions

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Endotracheal intubation with injection of liquid in the cuff

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- ASA 1,2 or 3 patients requiring general anesthesia for an elective urological or gynecological surgery predicted to last more than 2 hours

Exclusion Criteria

* Patient refusal
* Lidocaine allergy
* Any allergies to drugs or anesthetics used during the study
* Under 18 years of age
* Pregnant
* Previous airway surgery
* Cormack 3 or 4 or anticipated difficult airway
* Upper respiratory tract infection in the last month
* Active respiratory disease
* Chronic cough or throat pain
* Gastro-esophageal reflux disease or at risk for aspiration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Yanick Sansoucy

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanick Sansoucy, Doctor

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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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)

Estebe JP, Gentili M, Le Corre P, Dollo G, Chevanne F, Ecoffey C. Alkalinization of intracuff lidocaine: efficacy and safety. Anesth Analg. 2005 Nov;101(5):1536-1541. doi: 10.1213/01.ANE.0000180995.24211.89.

Reference Type BACKGROUND
PMID: 16244028 (View on PubMed)

Estebe JP, Dollo G, Le Corre P, Le Naoures A, Chevanne F, Le Verge R, Ecoffey C. Alkalinization of intracuff lidocaine improves endotracheal tube-induced emergence phenomena. Anesth Analg. 2002 Jan;94(1):227-30, table of contents. doi: 10.1097/00000539-200201000-00044.

Reference Type BACKGROUND
PMID: 11772834 (View on PubMed)

Dollo G, Estebe JP, Le Corre P, Chevanne F, Ecoffey C, Le Verge R. Endotracheal tube cuffs filled with lidocaine as a drug delivery system: in vitro and in vivo investigations. Eur J Pharm Sci. 2001 Jun;13(3):319-23. doi: 10.1016/s0928-0987(01)00119-1.

Reference Type BACKGROUND
PMID: 11384855 (View on PubMed)

Navarro LH, Lima RM, Aguiar AS, Braz JR, Carness JM, Modolo NS. The effect of intracuff alkalinized 2% lidocaine on emergence coughing, sore throat, and hoarseness in smokers. Rev Assoc Med Bras (1992). 2012 Mar-Apr;58(2):248-53.

Reference Type BACKGROUND
PMID: 22569622 (View on PubMed)

Souissi H, Frechette Y, Murza A, Masse MH, Marsault E, Sarret P, D'Aragon F, Parent AJ, Sansoucy Y. Intracuff 160 mg alkalinized lidocaine reduces cough upon emergence from N2O-free general anesthesia: a randomized controlled trial. Can J Anaesth. 2016 Jul;63(7):862-70. doi: 10.1007/s12630-016-0652-8. Epub 2016 Apr 13.

Reference Type DERIVED
PMID: 27075030 (View on PubMed)

Other Identifiers

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12182

Identifier Type: -

Identifier Source: org_study_id