CoughNCT01026129
Efficacy of Remifentanil Compared to Lidocaine on the Incidence of Coughing During Emergence of Anesthesia
A study testing Remifentanil and lidocaine in people with Cough and Anesthesia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cough, Anesthesia, Extubation
- What is being tested?
- Remifentanil and lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Current use of ACE inhibitor
- Chronic cough
- Asthma or severe COPD
- Pulmonary tract infection
- Anticipated difficult intubation
- Current use of opioids
Show all 10Show fewer
- Current use of cough medicine
- Contraindication to remifentanil or lidocaine
- Pregnancy
- Symptomatic cardiac, renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1
About this study
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.
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.
Read the 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.
- Conditions
- Cough, Anesthesia, Extubation
- Being tested
- Remifentanil, lidocaine
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Bolus dose of intravenous remifentanil 0,25 mcg/kg given once before emergence of general anesthesia.
RemifentanilDrug
Bolus dose of intravenous remifentanil 0.5 mck/kg given once before emergence of general anesthesia.
lidocaineDrug
Bolus dose of intravenous remifentanil 0.5 mck/kg given once before emergence of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil 0.25 mcg/kg | Experimental | Administration of a bolus dose of remifentanil 0.25 mcg/kg before emergence of a desflurane-based anesthesia. Receives: Drug: Remifentanil |
| Remifentanil 0.5 mcg/kg | Experimental | Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia. Receives: Drug: Remifentanil |
| Lidocaine | Active comparator | Bolus dose of intravenous remifentanil 1mg/kg given once before emergence of general anesthesia. Receives: Drug: lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coughing during emergence and the first ten minutes after extubation.
Measured: From emergence until 10 minutes after extubation
Secondary outcomes (2)
Time elapsed between the bolus dose of remifentanil or lidocaine and extubation.
Measured: From the administration of the study drug until extubation.
Incidence of sore throat one hour after extubation.
Measured: Assessed one hour after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- François Girard, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026129
- Sponsor's protocol ID
- FG 2010-002
- Status last verified
- Jul 2010
- First submitted
- 3 Dec 2009
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01026129
- Acronym / sponsor ID
- FG 2010-002
- Conditions
- Cough, Anesthesia, Extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remifentanil 0.25 mcg/kg | Experimental | Drug: RemifentanilAdministration of a bolus dose of remifentanil 0.25 mcg/kg before emergence of a desflurane-based anesthesia. |
| Remifentanil 0.5 mcg/kg | Experimental | Drug: RemifentanilAdministration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia. |
| Lidocaine | Active comparator | Drug: lidocaineBolus dose of intravenous remifentanil 1mg/kg given once before emergence of general anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- Current use of ACE inhibitor
- Chronic cough
- Asthma or severe COPD
- Pulmonary tract infection
- Anticipated difficult intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilBolus dose of intravenous remifentanil 0,25 mcg/kg given once before emergence of general anesthesia. | Drug | Remifentanil 0.25 mcg/kg |
| RemifentanilBolus dose of intravenous remifentanil 0.5 mck/kg given once before emergence of general anesthesia. | Drug | Remifentanil 0.5 mcg/kg |
| lidocaineBolus dose of intravenous remifentanil 0.5 mck/kg given once before emergence of general anesthesia. | Drug | Lidocaine |
Primary outcome
Incidence of coughing during emergence and the first ten minutes after extubation.
Time frame: From emergence until 10 minutes after extubation
2 secondary outcomes
Time elapsed between the bolus dose of remifentanil or lidocaine and extubation.
Time frame: From the administration of the study drug until extubation.
Incidence of sore throat one hour after extubation.
Time frame: Assessed one hour after extubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Girard, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil and lidocaine in people with Cough and Anesthesia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of coughing during emergence and the first ten minutes after extubation. (time frame: From emergence until 10 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2010.