Efficacy of Remifentanil Compared to Lidocaine on the Incidence of Coughing During Emergence of Anesthesia
| Tracking Information | |||||
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| First Received Date ICMJE | December 3, 2009 | ||||
| Last Updated Date | July 13, 2010 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01026129 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Remifentanil Compared to Lidocaine on the Incidence of Coughing During Emergence of Anesthesia | ||||
| Official Title ICMJE | Efficacy of a Bolus Dose of Remifentanil Compared to a Bolus Dose of Intravenous lidocaïne on the Incidence of Coughing During Emergence of Anesthesia. | ||||
| 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:
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. |
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| 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:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 93 | ||||
| Completion Date | July 2010 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01026129 | ||||
| Other Study ID Numbers ICMJE | FG 2010-002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | François Girard, MD FRCPC, Centre de recherche du CHUM (CRCHUM) | ||||
| Study Sponsor ICMJE | Centre hospitalier de l'Université de Montréal (CHUM) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Centre hospitalier de l'Université de Montréal (CHUM) | ||||
| Verification Date | July 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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