Efficacy of a Bolus Dose of Remifentanil Compared to a Bolus Dose of Intravenous lidocaïne on the Incidence of Coughing During Emergence of Anesthesia.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Incidence of coughing during emergence and the first ten minutes after extubation.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Remifentanil 0.25 mcg/kg
Administration of a bolus dose of remifentanil 0.25 mcg/kg before emergence of a desflurane-based anesthesia.
Intervention: Remifentanil (Drug)
Remifentanil 0.5 mcg/kg
Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia.
Intervention: Remifentanil (Drug)
Lidocaine
Bolus dose of intravenous remifentanil 1mg/kg given once before emergence of general anesthesia.
Intervention: lidocaine (Drug)
Outcomes
Primary Outcomes
Incidence of coughing during emergence and the first ten minutes after extubation.
Time Frame: From emergence until 10 minutes after extubation
Secondary Outcomes
- Time elapsed between the bolus dose of remifentanil or lidocaine and extubation.(From the administration of the study drug until extubation.)
- Incidence of sore throat one hour after extubation.(Assessed one hour after extubation.)