Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

NCT01774292 | Completed Phase 4

• 1 other identifier: 12182
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coughing; Extubation; Lidocaine; Endotracheal Cuff

Keywords

Impact of alkalized lidocaine on coughing at extubation

Outcome Measures

Primary Outcomes (1)

• Coughing

  24 hours after the end ofsurgery

Secondary Outcomes (3)

• Throat pain

  24 hours after the end of surgery

• Nausea and Vomiting

  24 hours after end of surgery

• Hoarseness of the voice

  24 hours after end of surgery

Study Arms (2)

Alkalized lidocaine

ACTIVE COMPARATOR

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

Procedure: Endotracheal intubation with injection of liquid in the cuff

Sterile saline

PLACEBO COMPARATOR

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

Procedure: Endotracheal intubation with injection of liquid in the cuff

Interventions

Endotracheal intubation with injection of liquid in the cuff PROCEDURE

Alkalized lidocaine; Sterile saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (6)

• 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

• 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.

  PMID: 16244028 BACKGROUND

• 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.

  PMID: 11772834 BACKGROUND

• 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.

  PMID: 11384855 BACKGROUND

• 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.

  PMID: 22569622 BACKGROUND

• 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.

  PMID: 27075030 DERIVED

MeSH Terms

Conditions

Cough

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Yanick Sansoucy, Doctor

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 23, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 30, 2015

Record last verified: 2015-10

Locations

CA (1)