The Effects of Beclomethasone Upper the Endotracheal Cuff on the Occurrence of Sore Throat at Extubation

Overview

The aim of the study is to test the effectiveness of a solutions of beclomethasone repeatedly instilled through the supraglottic line of the endotracheal tube on post-extubation airway disturbances related to tracheal intubation. The primary endpoint will be the decrease of the incidence of sore-throat 15 minutes and 12 hours after extubation. Secondary endpoints will regard the effects on hoarseness and cough.

Full Title of Study: “Does Beclomethasone Instillation Above the Cuff of Endotracheal Tubes Decrease the Occurrence of Postoperative Sore Throat? A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2017

Detailed Description

The study will be prospective, randomized, controlled. Patients will be premedicated with diazepam, 0.1 mg/Kg and scopolamine, 0.05 mg/Kg, i.m. one hour prior to their arrival in the operatory theatre. Anesthesia will be induced by fentanyl, 0.1 mg, and propofol, 1.5-2 mg/Kg. After obtaining muscle relaxation with cis-atracurium, 0.15 mg/Kg, a Taper Guard Evac Murphy Eye Oral Tracheal Tube (Mallinkrodt, Mirandola, Italy) with an internal diameter of 9 in men and 8 in women, will be positioned. These tubes have a line for suctioning above the cuff. The cuff pressure will be set to 20-30 cmH2O and checked every 6 hours with a proper inflating device. Patients will be connected to a mechanical ventilator and anesthesia will be maintained with sevoflurane 1-2.5% and remifentanil, 0.05-0.15 mcg/Kg/min. At the end of surgery, patients will be moved to the cardiac surgical intensive care, connected to a mechanical ventilator, and sedated with propofol and remifentanil until the conditions needed for weaning from the ventilator (control of bleeding, cardiovascular stability, thermal equilibrium) are achieved. Then, propofol infusion will be stopped and remifentanil dosage decreased to 0.02-0.05 mcg/Kg/min. After a successful t-tube trial of spontaneous breathing, tracheal tubes will be removed. Remifentanil infusion will be continued and dosage titrated on patient pain evaluated with a VAS scale; paracetamol 1 g will be given if need be.

Interventions

  • Drug: Beclomethasone
    • beclometasone, 0.8 mg of saline to a volume of 8 mL, three times through the line for suctioning above the cuff: a) after positioning the tube; b) at the arrival in the cardiac intensive care unit; c) just prior to start respiratory weaning
  • Drug: Placebo
    • patients will receive 8 mL of saline without any drug

Arms, Groups and Cohorts

  • Experimental: Beclomethasone
    • Patients will receive beclomethasone, 0.8 mg of saline to a volume of 8 mL, three times through the line for suctioning above the cuff: a) after positioning the tube; b) at the arrival in the cardiac intensive care unit; c) just prior to start respiratory weaning. The solution will be aspirated 15 minutes after the instillation.
  • Placebo Comparator: Placebo
    • Patients will receive 8 mL of saline without any drug.

Clinical Trial Outcome Measures

Primary Measures

  • Decrease of the incidence of sore-throat.
    • Time Frame: Fifteen minutes after removing the tracheal tube
    • Presence and intensity of sore throat by asking the patients to quantify it on a 0-3 scale Sore Throat Scoring System* 0 No sore throat Minimal sore throat, less severe than with a cold Moderate sore throat, similar to that noted with a cold Severe sore throat, more severe than noted with a cold

Secondary Measures

  • Decrease of the incidence of hoarseness
    • Time Frame: Fifteen minutes after removing the tracheal tube
    • Presence and degree of hoarseness by asking the patients to quantify it on a 0-3 scale (table 3). In addition patients will be asked to pronounce a prolonged “e” in order to assess the capacity to adduce vocal cords, an ENT evaluation will be requested. Hoarseness Scoring System* 0 No evidence of hoarseness Hoarseness that is noted by the patient only Hoarseness that is easily noted

Participating in This Clinical Trial

Inclusion Criteria

  • intensive care postoperative admission
  • tracheal intubation for a total lapse of time between 10 and 18 hours

Exclusion Criteria

  • age < 18,
  • hypersensitivity to FANS and/or corticosteroids,
  • a medical history positive for diseases affecting upper airways or trachea or causing cough, hoarseness, or voice disorders;
  • intubation after more than two attempts or with aids (i.e. stylets, Airtraq, Glidescope, Fibroscopy).

Gender Eligibility: All

Minimum Age: 18 Months

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Provider of Information About this Clinical Study
    • Principal Investigator: Temistocle Taccheri, MD, resident of Department of Anesthesia and Intensive Care , Policlinico A. Gemelli , Catholic University of the Sacred Heart in Rome – Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Overall Official(s)
    • Franco Cavaliere, MD, Principal Investigator, Department cardiovascular diseases A. Gemelli Polyclinic , University Sacred Heart in Rome
  • Overall Contact(s)
    • Temistocle Taccheri, MD, 3470526726, taccheri.temistocle@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.