NCT02114021

Brief Summary

ABSTRACT: The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. This study has not been carried out in Iran. 99 patients of either sex undergoing elective surgery were recruited in a single blind randomized study. The patients, using randomization table, were divided into three groups. Anesthetics and medications used during surgery were similar for all the patients. For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of medications were obtained.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

April 7, 2014

Last Update Submit

April 14, 2014

Conditions

Sore ThroatCough

Keywords

Syndrome incidence after intubationBetamethasone gellidocaine jellysore throatcoughhoarseness of voice

Outcome Measures

Primary Outcomes (9)

  • sore throat

    For the all the patients, the incidence of postoperative cough in 24 hours follow-up based on the different types of medications were obtained (using questionnaire).

    24 hours after surgery

  • cough

    For the all the patients, the incidence of postoperative cough in 1 hour follow-up periods based on the different types of medications were obtained (using questionnaire).

    1 hour after surgery

  • hoarseness of voice

    For the all patients, the incidence of postoperative hoarseness of the voice in 1 hour follow-up period based on the different types of medications were obtained (using questionnaire).

    1 hour after surgery

  • sore throat

    For the all the patients, the incidence of postoperative cough in 1 hour follow up based on the different types of medications were obtained (using questionnaire).

    1 hour after surgery

  • sore throat

    For the all the patients, the incidence of postoperative cough in 6 hours follow-up based on the different types of medications were obtained (using questionnaire).

    6 hours after surgery

  • cough

    For the all the patients, the incidence of postoperative cough in 6 hours follow-up periods based on the different types of medications were obtained (using questionnaire).

    6 hours after surgery

  • cough

    For the all the patients, the incidence of postoperative cough in 24 hours follow-up periods based on the different types of medications were obtained (using questionnaire).

    24 hours after surgery

  • hoarseness of voice

    For the all patients, the incidence of postoperative hoarseness of the voice in 6 hours follow-up period based on the different types of medications were obtained (using questionnaire).

    6 hours after surgery

  • hoarseness of voice

    For the all patients, the incidence of postoperative hoarseness of the voice in 24 hours follow-up period based on the different types of medications were obtained (using questionnaire).

    24 hours after surgery

Study Arms (3)

betamethasone gel

EXPERIMENTAL

betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

Drug: betamethasone gelDrug: distilled water

lidocaine jelly

EXPERIMENTAL

lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

Drug: lidocaine jellyDrug: distilled water

distilled water

PLACEBO COMPARATOR

betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

Interventions

betamethasone gelDRUG

betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

betamethasone gel
lidocaine jellyDRUG

the effect of lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

lidocaine jelly
distilled waterDRUG

The effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

betamethasone gellidocaine jelly

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years\<age\>15 years
  • no acute upper respiratory infections and no sore throat
  • candidate for elective surgery unrelated to the throat
  • The lack of airways difficulties
  • candidate for general anesthesia with intubation
  • no contraindications for receiving steroid
  • surgery time \< 240 minutes
  • intubation up to 2 times
  • tracheal tube cuff pressure = 25-30 cm H2o
  • fasting for 8-6 hours prior to surgery
  • ASA I and ASAII and
  • Surgery under general anesthesia and endotracheal intubation

You may not qualify if:

  • use of nasogastric tube or throat packs
  • patients with upper respiratory tract infection
  • patients on steroid therapy were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Booali Hospital, Islamic Azad University,

Tehran, Iran

Location

MeSH Terms

Conditions

PharyngitisCoughHoarseness

Interventions

betamethasone dipropionate, calcipotriol drug combination

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsVoice DisordersLaryngeal DiseasesNeurologic ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 15, 2014

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

IR(1)