Efficacy of Flurbiprofen Spray for Postoperative Sore Throat Following Double-Lumen Endobronchial Intubation

NCT07163429 | Active Not Recruiting

• 1 other identifier: ANE-2568-0331
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate whether topical flurbiprofen reduces the incidence and severity of postoperative sore throat (POST) and hoarseness in patients undergoing double-lumen tube (DLT) intubation for elective thoracic surgery. The main question is: Does topical flurbiprofen reduce POST and hoarseness compared with placebo in patients undergoing DLT intubation? Researchers will compare topical flurbiprofen spray with placebo spray. Participants will:

• Receive a DLT sprayed with either topical flurbiprofen or placebo before intubation.
• Be assessed for POST and hoarseness at 15 minutes, 2 hours, 12 hours, 24 hours, and 48 hours after surgery.

Conditions

Post Operative Sore Throat; Hoarseness

Keywords

Postoperative sore throat (POST); Double-lumen intubation; Thoracic surgery; Flurbiprofen spray; Airway complications

Outcome Measures

Primary Outcomes (1)

• Incidence of POST

  Presence or absence of postoperative sore throat (POST)

  Within 48 hours postoperatively

Secondary Outcomes (4)

• Severity of POST

  15 minutes, 2, 12, 24, and 48 hours postoperatively

• Incidence of hoarseness

  Within 48 hours postoperatively

• Severity of hoarseness

  15 minutes, 2, 12, 24, and 48 hours postoperatively

• Patient satisfaction

  48 hours postoperatively

Study Arms (2)

Flurbiprofen group

EXPERIMENTAL

Participants will receive topical flurbiprofen spray (one spray on the bronchial cuff and two spray on the tracheal cuff, with a total dose of 8.75 mg of flurbiprofen) applied to both the tracheal and bronchial cuffs of the double-lumen tube before intubation

Drug: Flurbiprofen 8.75 MG

Control group

PLACEBO COMPARATOR

Participants will receive placebo spray (0.9% normal saline) applied to both the tracheal and bronchial cuffs of the double-lumen tube before intubation.

Drug: Saline spray

Interventions

Saline spray DRUG

Topical administration of placebo spray (0.9% normal saline) applied in the same manner as the active intervention, with one spray to the bronchial cuff and two sprays to the tracheal cuff of the double-lumen tube before intubation.

Control group

Flurbiprofen 8.75 MG DRUG

Topical administration of flurbiprofen 8.75 mg spray applied directly to the tracheal and bronchial cuffs of the double-lumen endobronchial tube before intubation. A total of three sprays will be applied: one spray to the bronchial cuff and two sprays to the tracheal cuff, immediately before intubation.

Also known as: Flurbiprofen spray

Flurbiprofen group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 20-80 years
• Undergoing elective thoracic surgery
• Requiring DLT intubation for lung separation
• ASA physical status classification I-III
• Able to communicate and understand the study

You may not qualify if:

• Contraindications to use of flurbiprofen, including allergies to flurbiprofen or NSAIDs, active peptic ulcer/ hemorrhage, history of gastrointestinal bleeding or perforation, severe colitis, severe heart failure, chronic kidney disease (CKD) stage IV or end-stage kidney disease (ESRD), or liver failure
• Recent or recurrent upper respiratory tract infection
• History of sore throat or hoarseness within 1 month prior to surgery
• History of previous airway surgery
• Chronic pain conditions
• Pregnancy
• Withdrawal criteria
• Fail DLT intubation
• Inability to extubation at the end of surgery

Sponsors & Collaborators

• Kittitorn Supphapipat, MD: lead

Study Sites (1)

Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

Chiang Mai, Mueang, 50200, Thailand

Location

Related Publications (2)

• Uzture N, Menda F, Bilgen S, Keskin O, Temur S, Koner O. The Effect of Flurbiprofen on Postoperative Sore Throat and Hoarseness After LMA-ProSeal Insertion: A Randomised, Clinical Trial. Turk J Anaesthesiol Reanim. 2014 Jun;42(3):123-7. doi: 10.5152/TJAR.2014.35693. Epub 2014 Mar 11.

  PMID: 27366405 BACKGROUND

• Mazzotta E, Soghomonyan S, Hu LQ. Postoperative sore throat: prophylaxis and treatment. Front Pharmacol. 2023 Nov 23;14:1284071. doi: 10.3389/fphar.2023.1284071. eCollection 2023.

  PMID: 38074131 BACKGROUND

MeSH Terms

Conditions

Hoarseness

Interventions

Flurbiprofen

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Kittitorn Supphapipat, MD

  Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either topical flurbiprofen spray or placebo spray applied to the double-lumen tube cuffs before intubation. Outcomes will be assessed at multiple postoperative time points.

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

TH (1)