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Status unknownNCT02952157Updated Nov 2, 2016

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

A Phase 4 interventional study of Lidocaine jelly application and Normal saline application in Sore Throat, sponsored by Keimyung University Dongsan Medical Center. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Keimyung University Dongsan Medical Center · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sore Throat

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03

In context

Pharyngitis

252 studies on the registry are indexed under Pharyngitis; 36 are open to participants now.

This study's planned enrollment of 210 is above the median of 144 across 209 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

Keimyung University Dongsan Medical Center is the lead sponsor of 81 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • 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

Interventions

  • DrugLidocaine jelly application
  • DrugNormal saline application
06

What researchers measure

Primary outcomes

  1. Number of participants with sore throat

    Time frame: At 24 hr

Secondary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02952157
Lead sponsor
Keimyung University Dongsan Medical Center
Responsible party
Sponsor
First posted
Nov 2, 2016
Start date
Nov 2016
Primary completion
Nov 2016 (estimated)
Completion
Nov 2016 (estimated)
Last update
Nov 2, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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