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

This study has been completed.
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01489072
First received: December 5, 2011
Last updated: October 25, 2012
Last verified: October 2012
  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.

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489072

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
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 April 17, 2014