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

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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

Tracking Information
First Submitted Date  ICMJE December 21, 2016
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE October 31, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant on Sore Throat and Hemodynamics
Official Title  ICMJE 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 Description

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.

The secondary endpoint:

• Post operative upper airways symptoms. Power and Sample Size Calculator To detect a decrease in the incidence of pharyngolaryngeal symptoms from 60% to 45%, we calculated that we needed 150 patients per study arm (power of the study, 0,8; type I error, 0,05).

450 adult patients have to be scheduled for the study.

The study is double blind, randomized:

  • Group Topical lidocaine 4%:
  • Group NMBA
  • Control group Premedication: Paracetamol 2g General anaesthesia: TCI (Target Control of Infusion is a principle, an anesthesia infusion after protocol): Propofol and Remifentanil Surgical procedure: Not specified short lasting (<1 h) procedures The experienced anesthesiologist performing the intubating procedure will not be in the room until immediately before the intubation.

Postoperatively:

  • Oral paracetamol and codeine-fixed combination up to 1000 mg and 60 mg, respectively, every 6 h
  • When nausea and vomiting occurs postoperatively, ondansetron 4 mg IV administers as the drug of first choice followed by droperidol 0,625 mg IV if the nausea/vomiting persists.

Collected data:

  • Patient characteristics inclusive smoke habits
  • Intubation conditions according to the Copenhagen score
  • Blood pressure prior to laryngoscopy and after 1, 3, 5, 7, 9, 11, 13 and 15 minutes, then every 15 min.
  • Cuff pressure
  • Pharyngolaryngeal discomfort 2 and 24 hours (telephone interview if released from hospital) after extubation
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Intubation Complication
Intervention  ICMJE
  • 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
  • Drug: Muscle Relaxant (Rocuronium)
    After induction of anesthesia, the participants are given 0,6 mg/kg bodyweight intravenously.
    Other Name: Esmeron MSD
  • Other: No Muscle relaxant, no Lidocaine
    This group get general anesthesia without Rocuronium or Lidocaine
    Other Name: Control group
Study Arms  ICMJE
  • Lidocaine spray
    Endotracheal lidocaine spray prior to intubation
    Intervention: Drug: Lidocaine spray (2%)
  • Muscle relaxant
    Muscle relaxant prior to intubation
    Intervention: Drug: Muscle Relaxant (Rocuronium)
  • No Muscle relaxant, no Lidocaine
    'No Muscle relaxant, no Lidocaine Control group
    Intervention: Other: No Muscle relaxant, no Lidocaine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031808
Other Study ID Numbers  ICMJE AB3383
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No sharing plan so far.
Responsible Party Jan Sverre Vamnes, Ostfold Hospital Trust
Study Sponsor  ICMJE Ostfold Hospital Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jan Sverre Vamnes, MD, Ph.D. Senior consultant
PRS Account Ostfold Hospital Trust
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP