NCT02952157

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
Last Updated

November 2, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

October 20, 2016

Last Update Submit

October 30, 2016

Conditions

Sore Throat

Outcome Measures

Primary Outcomes (1)

  • Number of participants with sore throat

    At 24 hr

Secondary Outcomes (8)

  • Number of participants with sore throat

    At 1, 6, and 12 hr

  • Number of participants with hoarseness

    At 1, 6, 12 and 24 hr

  • Number of participants with throat numbness

    At 1, 6, 12 and 24 hr

  • Number of participants with nausea

    At 1, 6, 12 and 24 hr

  • Number of participants with vomiting

    At 1, 6, 12 and 24 hr

  • +3 more secondary outcomes

Study Arms (2)

Control

SHAM COMPARATOR

Normal saline will be applied to the endotracheal tube.

Drug: Normal saline application

Lidocaine

ACTIVE COMPARATOR

Lidocaine jelly will be applied to the endotracheal tube.

Drug: Lidocaine jelly application

Interventions

Lidocaine jelly applicationDRUG
Lidocaine
Normal saline applicationDRUG
Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

November 2, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share