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

NCT ID: NCT02687100

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-09-30

Brief Summary

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.

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.

Conditions

Anesthesia, Endotracheal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Beclomethasone

Intervention Type: DRUG

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

Placebo

Patients will receive 8 mL of saline without any drug.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

patients will receive 8 mL of saline without any drug

Interventions

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

Intervention Type: DRUG

Placebo

patients will receive 8 mL of saline without any drug

Intervention Type: DRUG

Other Intervention Names

Qvar, Beclovent, Vanceril, Vanceril DS

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Temistocle Taccheri

MD, resident of Department of Anesthesia and Intensive Care , Policlinico A. Gemelli , Catholic University of the Sacred Heart in Rome

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franco Cavaliere, MD

Role: PRINCIPAL_INVESTIGATOR

Department cardiovascular diseases A. Gemelli Polyclinic , University Sacred Heart in Rome

Other Identifiers

DMC

Identifier Type: -

Identifier Source: org_study_id