Efficacy of Remifentanil Compared to Lidocaine on the Incidence of Coughing During Emergence of Anesthesia
Primary Purpose
Cough, Anesthesia, Extubation
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Remifentanil
Remifentanil
lidocaine
Sponsored by
About this trial
This is an interventional prevention trial for Cough
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Remifentanil 0.25 mcg/kg
Remifentanil 0.5 mcg/kg
Lidocaine
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.
Bolus dose of intravenous remifentanil 1mg/kg given once before emergence of general 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 or lidocaine and extubation.
Incidence of sore throat one hour after extubation.
Full Information
NCT ID
NCT01026129
First Posted
December 3, 2009
Last Updated
July 13, 2010
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT01026129
Brief Title
Efficacy of Remifentanil Compared to Lidocaine on the Incidence of Coughing During Emergence of Anesthesia
Official Title
Efficacy of a Bolus Dose of Remifentanil Compared to a Bolus Dose of Intravenous lidocaïne on the Incidence of Coughing During Emergence of Anesthesia.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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. Among others, the role of lidocaine given intravenously, topically , or intra-cuff has been studied.
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 remifentanil (bolus dose of 0.25 mcg/kg or 0.5 mcg/kg) to lidocaine (bolus dose of 1mg/kg) when given prior to emergence to prevent perioperative coughing after a desflurane-based anesthesia.
Methods:
Induction of general anesthesia: 1.5-3 mg/kg propofol and 1-3 mcg/kg fentanyl. Neuromuscular relaxation at the discretion of the attending anesthesiologist.
Tracheal intubation using direct laryngoscopy.
Maintenance of general anesthesia: desflurane between 0.7 and 1.0 MAC, fentanyl 1 mcg/kg. Neuromuscular relaxation will be carried out at the discretion of the attending anesthesiologist.
No opioids should be given during the last 30 minutes of surgery.
Reversal of neuromuscular blockade is mandatory at the end of surgery.
At the end of surgery : discontinuation of desflurane.
Administration of the study drug: (bolus dose of remifentanil 0.25 mcg/kg, remifentanil 0.5 mcg/kg or lidocaine 1 mg/kg).
When the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds.
After eyes opening, ventilator will be stopped and the extubation performed.
Number of coughing episodes and their importance will be rated on a scale from 0 to 3 by a blinded observer during emergence and the first ten minutes after extubation.
Time elapsed between the administration of the bolus dose of the study drug to extubation will be recorded.
The presence of sore throat will be assessed one hour after extubation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Anesthesia, Extubation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Anticipated)
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
Experimental
Arm Description
Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Bolus dose of intravenous remifentanil 1mg/kg given once before emergence of general 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 mck/kg given once before emergence of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
lidocaine
Intervention Description
Bolus dose of intravenous remifentanil 0.5 mck/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 or lidocaine and extubation.
Time Frame
From the administration of the study drug 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
ASA 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Girard, 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
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Efficacy of Remifentanil Compared to Lidocaine on the Incidence of Coughing During Emergence of Anesthesia
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