NCT01838993

Brief Summary

We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

4 months

First QC Date

April 21, 2013

Last Update Submit

April 23, 2013

Conditions

Sore Throat

Keywords

anesthetics,local,lidocaine;nebulizers and vaporizers;complications,intubation,intratracheal.

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Non invasive blood pressure every min for 3 min

    3 min

Secondary Outcomes (1)

  • Post operative sore throat

    3 days

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Inhalation of lidocaine before intubation

Drug: Lidocaine inhalation

Control

PLACEBO COMPARATOR

Normal saline inhalation before intubation

Drug: Placebo

Interventions

Lidocaine inhalationDRUG

Lidocaine inhalation before intubation

Lidocaine
PlaceboDRUG
Control

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I or II. Patients scheduled for elective surgery under general anesthesia with orotracheal intubation

You may not qualify if:

  • patient's refusal to join, major surgery or expected operation duration longer than 3 hours, patients with a anticipated difficult airway, requiring a nasogastric tube in peri-operative stage, having recent upper respiratory tract infection (within 1 week) or pre-existing sore throat.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Taipei City Hospital

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Chen Yen Po, MD

    New Taipei City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Yen Po, MD

CONTACT

drbrianchan@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 21, 2013

First Posted

April 24, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations

TW(1)