Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Cough Anesthesia |
Drug: Remifentanil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Comparison of the Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia. |
- 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 ]
- Time elapsed between the bolus dose of remifentanil and extubation [ Time Frame: Assessed at emergence of general anesthesia ] [ Designated as safety issue: Yes ]
- Incidence of sore throat one hour after extubation [ Time Frame: Assessed one hour after extubation ] [ Designated as safety issue: Yes ]
| Enrollment: | 180 |
| Study Start Date: | April 2012 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Remifentanil 0.25 mcg/kg
Administration of a bolus dose of remifentanil 0.25 mcg/kg before emergence of a desflurane-based anesthesia
|
Drug: Remifentanil
Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia
|
|
Active Comparator: Remifentanil 0.5 mcg/kg
Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia
|
Drug: Remifentanil
Bolus dose of intravenous remifentanil 0.5 mcg/kg given once before emergence of general 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.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Quebec | |
| Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Principal Investigator: | Nathalie Massicotte, MD, FRCPC | Centre Hospitalier de l'Université de Montréal |
More Information
No publications provided
| Responsible Party: | Centre hospitalier de l'Université de Montréal (CHUM) |
| ClinicalTrials.gov Identifier: | NCT01489072 History of Changes |
| Other Study ID Numbers: | NM 2012-002 |
| Study First Received: | December 5, 2011 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Anesthetics Remifentanil Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General |
ClinicalTrials.gov processed this record on May 23, 2013