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Efficacy of Remifentanil Compared to Lidocaine on the Incidence of Coughing During Emergence of Anesthesia

This study has been completed.
Sponsor:
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01026129
First received: December 3, 2009
Last updated: July 13, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Cough
Anesthesia
Extubation
Drug: Remifentanil
Drug: lidocaine

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: Efficacy of a Bolus Dose of Remifentanil Compared to a Bolus Dose of Intravenous lidocaïne 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 or lidocaine and extubation. [ Time Frame: From the administration of the study drug until extubation. ] [ 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 ]

Estimated Enrollment: 93
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (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.
Experimental: 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 mck/kg given once before emergence of general anesthesia.
Active Comparator: Lidocaine
Bolus dose of intravenous remifentanil 1mg/kg given once before emergence of general anesthesia.
Drug: lidocaine
Bolus dose of intravenous remifentanil 0.5 mck/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. 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.

Methods:

  • Induction of general anesthesia: 1.5-3 mg/kg propofol and 1-3 mcg/kg fentanyl. Neuromuscular relaxation at the discretion of the attending anesthesiologist.
  • Tracheal intubation using direct laryngoscopy.
  • Maintenance of general anesthesia: desflurane between 0.7 and 1.0 MAC, fentanyl 1 mcg/kg. Neuromuscular relaxation will be carried out at the discretion of the attending anesthesiologist.
  • No opioids should be given during the last 30 minutes of surgery.
  • Reversal of neuromuscular blockade is mandatory at the end of surgery.
  • At the end of surgery : discontinuation of desflurane.
  • Administration of the study drug: (bolus dose of remifentanil 0.25 mcg/kg, remifentanil 0.5 mcg/kg or lidocaine 1 mg/kg).
  • When the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds.
  • After eyes opening, ventilator will be stopped and the extubation performed.
  • Number of coughing episodes and their importance will be rated on a scale from 0 to 3 by a blinded observer during emergence and the first ten minutes after extubation.
  • Time elapsed between the administration of the bolus dose of the study drug to extubation will be recorded.
  • The presence of sore throat will be assessed one hour after extubation.
  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026129

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)
Investigators
Principal Investigator: François Girard, MD, FRCPC Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: François Girard, MD FRCPC, Centre de recherche du CHUM (CRCHUM)
ClinicalTrials.gov Identifier: NCT01026129     History of Changes
Other Study ID Numbers: FG 2010-002
Study First Received: December 3, 2009
Last Updated: July 13, 2010
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014