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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031808
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jan Sverre Vamnes, Ostfold Hospital Trust

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.


Condition or disease Intervention/treatment Phase
Intubation Complication Drug: Lidocaine spray (2%) Drug: Muscle Relaxant (Rocuronium) Other: No Muscle relaxant, no Lidocaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant; Impact on Postoperative Sore Throat and Haemodynamics
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Lidocaine spray
Endotracheal lidocaine spray prior to intubation
Drug: Lidocaine spray (2%)
Spraying trachea from 2 cm above the vocal cords and 5 cm down with a straw with multiple side holes
Other Name: Xylocain 2% Astra Zeneca

Muscle relaxant
Muscle relaxant prior to intubation
Drug: Muscle Relaxant (Rocuronium)
After induction of anesthesia, the participants are given 0,6 mg/kg bodyweight intravenously.
Other Name: Esmeron MSD

No Muscle relaxant, no Lidocaine
'No Muscle relaxant, no Lidocaine Control group
Other: No Muscle relaxant, no Lidocaine
This group get general anesthesia without Rocuronium or Lidocaine
Other Name: Control group




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. 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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled elective surgery with general anesthesia and planned endotracheal intubation.

Exclusion Criteria:

  • ASA≥3,
  • 20>BMI<35
  • Allergy to local anesthetics or neuromuscular blocking agents.
  • The ASA physical status classification system is a system for assessing the fitness of patients before surgery. BMI is Body Mass Index measured in kilograms/square meter.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031808


Contacts
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Contact: Jan Sverre Vamnes, MD, Ph.D +47 913 05 016 jan.sverre.vamnes@so-hf.no
Contact: Knut Inge Solbakk, MD +47 909 33 106 knut.inge.solbakk@so-hf.no

Locations
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Norway
Ostfold Hospital Trust, Moss Recruiting
Grålum, Ostfold, Norway, 1714
Contact: Jan Sverre Vamnes, MD, Ph.D.    +47 91608896    janvam@so-hf.no   
Contact: Knut Inge Solbakk, md    +47 90933106    knisol@so-hf.no   
Sponsors and Collaborators
Ostfold Hospital Trust
Investigators
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Study Chair: Jan Sverre Vamnes, MD, Ph.D. Senior consultant

Publications:

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Responsible Party: Jan Sverre Vamnes, Senior consultant, Ph.D., Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT03031808    
Other Study ID Numbers: AB3383
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing plan so far.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharyngitis
Muscle Hypotonia
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Rocuronium
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents