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Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff

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ClinicalTrials.gov Identifier: NCT02952157
Recruitment Status : Unknown
Verified October 2016 by Keimyung University Dongsan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Keimyung University Dongsan Medical Center

Brief Summary:
Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.

Condition or disease Intervention/treatment Phase
Sore Throat Drug: Lidocaine jelly application Drug: Normal saline application Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff
Study Start Date : November 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Sham Comparator: Control
Normal saline will be applied to the endotracheal tube.
Drug: Normal saline application
Active Comparator: Lidocaine
Lidocaine jelly will be applied to the endotracheal tube.
Drug: Lidocaine jelly application



Primary Outcome Measures :
  1. Number of participants with sore throat [ Time Frame: At 24 hr ]

Secondary Outcome Measures :
  1. Number of participants with sore throat [ Time Frame: At 1, 6, and 12 hr ]
  2. Number of participants with hoarseness [ Time Frame: At 1, 6, 12 and 24 hr ]
  3. Number of participants with throat numbness [ Time Frame: At 1, 6, 12 and 24 hr ]
  4. Number of participants with nausea [ Time Frame: At 1, 6, 12 and 24 hr ]
  5. Number of participants with vomiting [ Time Frame: At 1, 6, 12 and 24 hr ]
  6. Number of participants with cough [ Time Frame: At 1, 6, 12 and 24 hr ]
  7. Number of participants with dry mouth [ Time Frame: At 1, 6, 12 and 24 hr ]
  8. Number of participants with additional pain medication [ Time Frame: At 24 hr ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III
  • Patients scheduled for general anesthesia with endotracheal intubation
  • Patients scheduled for surgery which duration is expected to less than 3 hr

Exclusion Criteria:

  • Difficult airway
  • Rapid sequence induction
  • Recent sore throat
  • Recent upper respiratory infection
  • Asthma
  • Chronic obstructive pulmonary disease
  • Chronic cough
  • Pregnancy
  • Allergy to lidocaine
  • Friable teeth
  • History of head and neck surgery
  • Multiple intubation attempts
  • Regional anesthetic agents
  • Gastric tube
  • Dexamethasone

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Responsible Party: Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT02952157    
Other Study ID Numbers: LidoTaper
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Lidocaine
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