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

This study has been completed.
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01489072
First received: December 5, 2011
Last updated: October 25, 2012
Last verified: October 2012

December 5, 2011
October 25, 2012
April 2012
October 2012   (final data collection date for primary outcome measure)
Incidence of coughing during emergence and the first ten minutes after extubation [ Time Frame: From emergence until 10 minutes after extubation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01489072 on ClinicalTrials.gov Archive Site
  • Time elapsed between the bolus dose of remifentanil and extubation [ Time Frame: Assessed at emergence of general anesthesia ] [ Designated as safety issue: Yes ]
  • Incidence of sore throat one hour after extubation [ Time Frame: Assessed one hour after extubation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia
Comparison of the Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia.

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).

Emergence is an important period of general anesthesia during which several problems can occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence of general anesthesia.

Most patients will cough during emergence. Different techniques and drugs have been studied to reduce coughing during emergence.

There is some evidence supporting the administration of intravenous opioids prior to emergence of general anesthesia to reduce perioperative coughing, agitation and haemodynamic stimulation. However, depending on the type of opioids given, this may delay the emergence from anesthesia. The effect of a remifentanil infusion given in combination with isoflurane as the volatile agent has been shown to reduce the incidence of perioperative coughing without delaying the emergence of anesthesia. The effect of a small bolus of remifentanil given prior to emergence to prevent perioperative coughing has yet to be studied.

Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has led to earlier discharge and more rapid resumption of normal activities after surgery. However, an incidence of coughing around 70% has been reported after a desflurane-based anesthesia.

This study will compare the effects of two bolus doses of remifentanil (0.25 mcg/kg to 0.5 mcg/kg) when given prior to emergence to prevent perioperative coughing after a desflurane-based anesthesia.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Cough
  • Anesthesia
  • Drug: Remifentanil
    Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia
  • Drug: Remifentanil
    Bolus dose of intravenous remifentanil 0.5 mcg/kg given once before emergence of general anesthesia
  • Experimental: Remifentanil 0.25 mcg/kg
    Administration of a bolus dose of remifentanil 0.25 mcg/kg before emergence of a desflurane-based anesthesia
    Intervention: Drug: Remifentanil
  • Active Comparator: Remifentanil 0.5 mcg/kg
    Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia
    Intervention: Drug: Remifentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01489072
NM 2012-002
No
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Principal Investigator: Nathalie Massicotte, MD, FRCPC Centre Hospitalier de l'Université de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP