Efficacy of Alkalinized Lidocaine Compared to 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
Alkalinized lidocaine
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 oral endotracheal intubation (excluding head and neck surgery)
- Expected duration of surgery of at least 1.5 hour.
Exclusion Criteria:
- Current use of ACE inhibitor
- 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, lidocaine
- Pregnancy
- Symptomatic cardiac, renal or hepatic disease
Sites / Locations
- Centre Hospitalier de l'Université de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Remifentanil 0.25 mcg/kg
Alkalinized lidocaine
Arm Description
Administration of a bolus dose of intravenous remifentanil before emergence of a desflurane-based anesthesia
Administration of alkalinized lidocaine in the endotracheal tube cuff
Outcomes
Primary Outcome Measures
Incidence of coughing during emergence and after extubation
Secondary Outcome Measures
Time to emergence
Incidence of sore throat one hour after extubation
Full Information
NCT ID
NCT01451840
First Posted
October 11, 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
NCT01451840
Brief Title
Efficacy of Alkalinized Lidocaine Compared to Remifentanil on the Incidence of Coughing During Emergence of Anesthesia
Official Title
Efficacy of Alkalinized Lidocaine in the Endotracheal Tube Cuff Compared to a Bolus Dose of Intravenous 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
January 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 alkalinized lidocaine in the endotracheal tube cuff to a bolus dose of 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 alkalinized lidocaine in the endotracheal tube cuff will reduce the incidence of perioperative coughing after a desflurane-based anesthesia.
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.
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. Different techniques and drugs have been studied to reduce coughing during emergence.
Among others, the role of lidocaine given intravenously, topically, or intracuff has been studied. The use of intracuff alkalinized lidocaine has been proven effective to reduce the incidence of coughing during emergence of anesthesia.
Furthermore, there is some evidence supporting the administration of intravenous opioids prior to emergence of general anesthesia to reduce perioperative coughing, agitation and hemodynamic 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. Bolus doses of remifentanil have also been proven effective to reduce the hemodynamic response to extubation.
The effect of these two modalities (alkalinized lidocaine and remifentanil) have never been compared. This study will assess their efficacy 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
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil 0.25 mcg/kg
Arm Type
Active Comparator
Arm Description
Administration of a bolus dose of intravenous remifentanil before emergence of a desflurane-based anesthesia
Arm Title
Alkalinized lidocaine
Arm Type
Experimental
Arm Description
Administration of alkalinized lidocaine in the endotracheal tube cuff
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)
Alkalinized lidocaine
Intervention Description
Administration of alkalinized lidocaine in the endotracheal tube cuff
Primary Outcome Measure Information:
Title
Incidence of coughing during emergence and after extubation
Time Frame
From emergence until 10 minutes after extubation
Secondary Outcome Measure Information:
Title
Time to emergence
Time Frame
From the discontinuation of Desflurane until extubation
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 oral endotracheal intubation (excluding head and neck surgery)
Expected duration of surgery of at least 1.5 hour.
Exclusion Criteria:
Current use of ACE inhibitor
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, lidocaine
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
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Alkalinized Lidocaine Compared to Remifentanil on the Incidence of Coughing During Emergence of Anesthesia
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