SUBGLOTTIC INSTILLATION OF FLURBIPROFENE TO PREVENT LARYNGEAL INFLAMMATION FOLLOWING ENDOTRACHEAL INTUBATION: PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED PILOT STUDY

SUBGLOTTIC INSTILLATION OF FLURBIPROFENE TO PREVENT LARYNGEAL INFLAMMATION FOLLOWING ENDOTRACHEAL INTUBATION: PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED PILOT STUDY - SORE TROATH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000886-17-IT

Enrollment

Registered

2020-10-21

Start date

2020-11-02

Completion date

Unknown

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sore throat generally associated with cough and hoarseness after orotracheal intubation. MedDRA version: 23.1 Level: LLT Classification code 10041367 Term: Sore throat System Organ Class: 100000004855

Interventions

Product Name: FLURBIPROFENE Product Code: [R02AX01] Pharmaceutical Form: Mouthwash INN or Proposed INN: FLURBIPROFENE CAS Number: 5104-49-4 Current Sponsor code: MERCK Concentration unit: % percent Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ¿ Patients undergoing 9-12 hours orotracheal intubation for aortocoronary bypass, valve replacement ¿ Plastic surgery in extracorporeal circulation ¿ Patient aged between 50 and 75 ¿ Patients in NYHA class I and II ¿ Patients who have given their written consent to the study and treatment of their clinical data for the purpose of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Exclusion criteria ¿ Previous upper airway surgery ¿ A positive history of recent acute pathologies or chronic pathologies of the upper airways ¿ Nicotine addiction ¿ Positive history of difficult intubation including objective examination suggestive of difficult orotracheal intubation (Mallampati = 3) ¿ Orotracheal intubation with more than two attempts or with the aid of devices (spindles, Airtrag, Fibroscopy) ¿ Nasotracheal intubation ¿ Positive history of gastroesophageal reflux ¿ Patients participating in other experimental trials ¿ Patients who have not given their written consent to participate in the study and have specifically refused the use of their clinical data for the purpose of the study and have not given their consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of the protocol is to evaluate the effectiveness of a solution of flurbiprofen through the subglottic suction port on the incidence and intensity of the POST in patients undergoing cardiac surgery in extracorporeal circulation and for this reason subjected to endotracheal intubation lasting several hours.;Secondary Objective: Assess the effects on the incidence and intensity of cough and hoarseness;Primary end point(s): Primary endpoint is to evaluate the effectiveness of a solution of flurbiprofen through the subglottic suction port on the incidence and intensity of the POST in patients undergoing cardiac surgery in extracorporeal circulation and for this reason subjected to endotracheal intubation lasting several hours.;Timepoint(s) of evaluation of this end point: ¿T0 Anesthesiologic visit and request for informed consent ¿T0.25 15 minutes after endotracheal tube removal ¿T3 three hours after endotracheal tube removal ¿T12 twelve hours after endotracheal tube removal (1 postoperative day) ¿T 36 36 hours after endotracheal tube removal (2 postoperative day)	—

Measure

Time frame

Main Objective: The purpose of the protocol is to evaluate the effectiveness of a solution of flurbiprofen through the subglottic suction port on the incidence and intensity of the POST in patients undergoing cardiac surgery in extracorporeal circulation and for this reason subjected to endotracheal intubation lasting several hours.;Secondary Objective: Assess the effects on the incidence and intensity of cough and hoarseness;Primary end point(s): Primary endpoint is to evaluate the effectiveness of a solution of flurbiprofen through the subglottic suction port on the incidence and intensity of the POST in patients undergoing cardiac surgery in extracorporeal circulation and for this reason subjected to endotracheal intubation lasting several hours.;Timepoint(s) of evaluation of this end point: ¿T0 Anesthesiologic visit and request for informed consent ¿T0.25 15 minutes after endotracheal tube removal ¿T3 three hours after endotracheal tube removal ¿T12 twelve hours after endotracheal tube removal (1 postoperative day) ¿T 36 36 hours after endotracheal tube removal (2 postoperative day)

—

Secondary

Measure	Time frame
Secondary end point(s): Assess the effects on the incidence and intensity of cough and hoarseness.;Timepoint(s) of evaluation of this end point: ¿ T0.25 15 minutes after endotracheal tube removal ¿ T3 three hours after endotracheal tube removal ¿ T12 twelve hours after endotracheal tube removal (1 postoperative day) ¿ T 36 36 hours after endotracheal tube removal (2 postoperative day)	—

Countries

Italy

Contacts

Public ContactDirezione Scientifica Fondazione Po

Direzione scientifica Fondazione Policlinico A.Gemelli IRCCS

direzione.scientifica@policlinicogemelli.it0630155701

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026