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NCT Number: NCT02114021

Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of

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.

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Key information

Conditions

Sore Throat Cough Hoarseness Infections Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Stomatognathic Diseases Voice Disorders

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Anesthesiology, Booali Hospital, Islamic Azad University,

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50 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

Exclusion criteria

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

Treatment and study plan

betamethasone gel

Drug

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

Lidocaine jelly

Drug

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

distilled water

Drug

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

Primary outcomes

  1. sore throat

    Time frame: 24 hours after surgery

    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).

  2. cough

    Time frame: 1 hour after surgery

    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).

  3. hoarseness of voice

    Time frame: 1 hour after surgery

    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).

  4. sore throat

    Time frame: 1 hour after surgery

    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).

  5. sore throat

    Time frame: 6 hours after surgery

    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. cough

    Time frame: 6 hours after surgery

    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).

  7. cough

    Time frame: 24 hours after surgery

    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).

  8. hoarseness of voice

    Time frame: 6 hours after surgery

    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).

  9. hoarseness of voice

    Time frame: 24 hours after surgery

    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).

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Islamic Azad University, Sanandaj

Registry information

Official study title

Effect of Betamethasone Gel and Lidocaine Jelly Applied Over Tracheal Tube Cuff on Post Operative Sore Throat, Cough and Hoarseness of Voice on the Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 15, 2014
Registry last updated
Apr 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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