Efficacy of Remifentanil Compared to Lidocaine on the Incidence of Coughing During Emergence of Anesthesia

NCT01026129 | Completed

• 1 other identifier: FG 2010-002
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the effects of a bolus dose of remifentanil to a bolus dose of lidocaine given prior to the emergence of anesthesia:

• on the incidence of perioperative coughing
• on the time needed for the emergence of a desflurane-based anesthesia
• on the incidence of sore throat after extubation. Our hypothesis is that the use of a remifentanil bolus dose given prior to emergence of a desflurane-based anesthesia will reduce the incidence of perioperative coughing from 70% to 35% compared to lidocaine.

Conditions

Cough; Anesthesia; Extubation

Outcome Measures

Primary Outcomes (1)

• Incidence of coughing during emergence and the first ten minutes after extubation.

  From emergence until 10 minutes after extubation

Secondary Outcomes (2)

• Time elapsed between the bolus dose of remifentanil or lidocaine and extubation.

  From the administration of the study drug until extubation.

• Incidence of sore throat one hour after extubation.

  Assessed one hour after extubation.

Study Arms (3)

Remifentanil 0.25 mcg/kg

EXPERIMENTAL

Administration of a bolus dose of remifentanil 0.25 mcg/kg before emergence of a desflurane-based anesthesia.

Drug: Remifentanil

Remifentanil 0.5 mcg/kg

EXPERIMENTAL

Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia.

Drug: Remifentanil

Lidocaine

ACTIVE COMPARATOR

Bolus dose of intravenous remifentanil 1mg/kg given once before emergence of general anesthesia.

Drug: lidocaine

Interventions

Remifentanil DRUG

Bolus dose of intravenous remifentanil 0,25 mcg/kg given once before emergence of general anesthesia.

Remifentanil 0.25 mcg/kg

lidocaine DRUG

Bolus dose of intravenous remifentanil 0.5 mck/kg given once before emergence of general anesthesia.

Lidocaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years
• ASA physical status 1-3
• Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation (excluding head and neck surgery)

You may not qualify if:

• Current use of ACE inhibitor
• Chronic cough
• Asthma or severe COPD
• Pulmonary tract infection
• Anticipated difficult intubation
• Current use of opioids
• Current use of cough medicine
• Contraindication to remifentanil or lidocaine
• Pregnancy
• Symptomatic cardiac, renal or hepatic disease

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Cough

Interventions

Remifentanil; Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• François Girard, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

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: December 3, 2009
• First Posted: December 4, 2009
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 14, 2010

Record last verified: 2010-07

Locations

CA (1)