Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia
Primary Purpose
Cough, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Remifentanil
Remifentanil
Sponsored by
About this trial
This is an interventional prevention trial for Cough
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remifentanil 0.25 mcg/kg
Remifentanil 0.5 mcg/kg
Arm Description
Administration of a bolus dose of remifentanil 0.25 mcg/kg before emergence of a desflurane-based anesthesia
Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia
Outcomes
Primary Outcome Measures
Incidence of coughing during emergence and the first ten minutes after extubation
Secondary Outcome Measures
Time elapsed between the bolus dose of remifentanil and extubation
Incidence of sore throat one hour after extubation
Full Information
NCT ID
NCT01489072
First Posted
December 5, 2011
Last Updated
October 25, 2012
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT01489072
Brief Title
Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia
Official Title
Comparison of the Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil 0.25 mcg/kg
Arm Type
Experimental
Arm Description
Administration of a bolus dose of remifentanil 0.25 mcg/kg before emergence of a desflurane-based anesthesia
Arm Title
Remifentanil 0.5 mcg/kg
Arm Type
Active Comparator
Arm Description
Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Bolus dose of intravenous remifentanil 0.5 mcg/kg given once before emergence of general anesthesia
Primary Outcome Measure Information:
Title
Incidence of coughing during emergence and the first ten minutes after extubation
Time Frame
From emergence until 10 minutes after extubation
Secondary Outcome Measure Information:
Title
Time elapsed between the bolus dose of remifentanil and extubation
Time Frame
Assessed at emergence of general anesthesia
Title
Incidence of sore throat one hour after extubation
Time Frame
Assessed one hour after extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Massicotte, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia
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