Clinical Trial: Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant on Sore Throat and Hemodynamics

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant; Impact on Postoperative Sore Throat and Haemodynamics

Brief Summary:

When a surgical procedure is performed under general anesthesia, the Airways are often secured With an endotracheal tube. Some patients experience sore throat thereafter. Studies have shown a reduction of these side effects when by use of muscle relaxants or a lidocain spray prior to the intubation. At Ostfold Hospital Trust, the investigators use one of the two methods or nothing. These methods will be studied systematically.

Heart rate and blood pressure rise during the intubation procedure. The investigators will also study the differences between the groups.

Detailed Summary:

Post-operative sore throat and cough are common complications of endotracheal intubation and occurs in 30% to 70% of patients. Spraying with Lidocaine reduces this incident of postoperative sore Throat (POST). The use of neuromuscular blocking agents (NMBA) alone will also diminish the incidence of adverse postoperative upper airway symptoms. The use of topical Lidocaine is shown to reduce the cardiovascular responses during and after endotracheal intubation.

Hypertension and tachycardia as a response to endotracheal intubation are probably of little consequence in healthy individuals. These reactions might though be harmful in patients with cardiovascular diseases.

Postoperative sore throat is an undesired outcome for the patient. Topical or systemic pharmacological interventions is shown to reduce the POST.

Our anesthetists practice very different. The investigators sometime use topical lidocaine 2% as a spray, sometime muscle relaxants and often nothing but propofol and remifentanil prior to laryngoscopy an endotracheal intubation.

The objective of this study is to determine, whether the use of topical administered lidocaine, 2 %, has a better impact on POST compared with NMBA alone in general anesthesia with propofol and remifentanil. Patients receiving nothing but propofol and remifentanil will be the reference group. Assessment of the intubation conditions will be done according to a standard scheme

The primary endpoint:

• Differences in the intubation conditions between the three groups.
• Cardiovascular responses caused by the laryngoscopy and intubation. Sponsor: Ostfold Hospital Trust
  

  Current Primary Outcome:

  • Sore Throat postoperative. Assessment of complaints and changes in complaints [ Time Frame: 2 h and 24 h after extubation ]
    Postoperative sore throat, described 2 h and 24 h after extubation. If the patient has sore throat or is hoarse, the complaint is assessed on a VAS (Visual Analogue Scale) 1 - 10.
  • Intubation conditions directly after induction of anesthesia [ Time Frame: 90 sec. after established general anesthesia ]
    Describes the intubation conditions: Jaw relaxation, resistance to laryngoscopy blade, the position and movement of vocal cords, the movement of limbs and coughing. Each variable rates as excellent, good or poor. Intubation conditions are many variables described once and should not be divided into several outcomes.
  • Hemodynamic parameters, change in HR (Heart Rate) is being assessed [ Time Frame: Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.) ]
    Describes changes in HR (Heart Rate)
  • Hemodynamic parameters, change in BP (blood pressure) is being assessed [ Time Frame: Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.) ]
    Describes changes in BP(Blood Pressure)
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Ostfold Hospital Trust
  

  Dates:
  Date Received: December 21, 2016
  Date Started: January 2017
  Date Completion: December 2017
  Last Updated: January 30, 2017
  Last Verified: January 2017