Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia

NCT01489072 | Completed

• 1 other identifier: NM 2012-002
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the effects of two bolus doses of intravenous remifentanil 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. The investigators hypothesis is that the use of a higher remifentanil bolus dose (0.5 mcg/kg) given prior to emergence of a desflurane-based anesthesia will reduce the incidence of perioperative coughing when compared to a lower dose of remifentanil (0.25 mcg/kg).

Conditions

Cough; Anesthesia

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 and extubation

  Assessed at emergence of general anesthesia

• Incidence of sore throat one hour after extubation

  Assessed one hour after extubation

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: Remifentanil

Interventions

Remifentanil DRUG

Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia

Remifentanil 0.25 mcg/kg

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

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

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

Study Officials

• Nathalie Massicotte, 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 9, 2011
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 29, 2012

Record last verified: 2012-10

Locations

CA (1)