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NCT Number: NCT01489072

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

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).

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Key information

Conditions

Cough Anesthesia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia

Primary outcomes

  1. Incidence of coughing during emergence and the first ten minutes after extubation

    Time frame: From emergence until 10 minutes after extubation

Secondary outcomes

  1. Time elapsed between the bolus dose of remifentanil and extubation

    Time frame: Assessed at emergence of general anesthesia

  2. Incidence of sore throat one hour after extubation

    Time frame: Assessed one hour after extubation

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 9, 2011
Registry last updated
Oct 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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