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Clinical Trials/NCT01489072
NCT01489072CompletedNot Applicable

Comparison of the Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia.

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country180 target enrollmentStarted: April 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
180
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 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).

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.

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
  • 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

Arms & Interventions

Remifentanil 0.25 mcg/kg

Experimental

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

Active Comparator

Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia

Intervention: Remifentanil (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 and extubation(Assessed at emergence of general anesthesia)
  • Incidence of sore throat one hour after extubation(Assessed one hour after extubation)

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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