Effect of Intravenous Dynastat on Postoperative Sore Throat (NCT03915561) | Clinical Trial Compass
UnknownPhase 2
Effect of Intravenous Dynastat on Postoperative Sore Throat
Taiwan140 participantsStarted 2019-03-01
Plain-language summary
A postoperative sore throat (POST) after tracheal intubation is one of the most common postoperative problems causing dissatisfaction to participants, including sore throat, dry throat, cough, sputum, hoarseness and even dysphagia. Both nonpharmacological and pharmacological measures have been attempted to alleviate the incidence and severity of POST with variable success. Airway inflammation may be important in the pathogenesis of these symptoms in intubated participants but however, there was still no study to investigate the effect of cyclooxygenase-2 (COX-2) for the prevention of POST. So, the investigators' study will be the first one to investigate if perioperatively intravenous (IV) Dynastat injection can be used as a new indication for POST prevention.
Who can participate
Age range
20 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* American Society of Anesthesiologists physical status 1 and 2
* Requiring general anesthesia with endotracheal intubation (ETGA) for elective non-cardiac surgery
* The anesthetic time after intubation will need 90 minutes at least.
Exclusion Criteria:
* Those with a preexisting cough, hoarseness or a sore throat
* Smoker
* History of asthma or chronic obstructive pulmonary disorder
* Vocal performer by occupation
* Recent or recurrent respiratory tract infection
* Risk factors for postoperative aspiration, for example obesity, pregnancy
* Allergic reaction to Dynastat, acetylsalicylic acid, sulfonamide or NSAIDs.
* Active GI bleeding or gastric ulcer
* Third trimester and during lactation
* Anticipated difficult intubation
* Mallampati grade \>2
* Difficult mask ventilation requiring oral or nasal airway
* Cormack and Lehane grade III and IV on laryngoscopy
* Intubation attempt \>1
* Moderate to severe liver dysfunction (Child-Pugh score \>7)
* Severe renal dysfunction (Ccr \< 30 ml/min)
* Congestive heart failure (NYHA II-IV)
* Those requiring orogastric or nasogastric tubes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The early incidence of POST
Timeframe: The early incidence will be assessed between 1 and 2 hours after surgery
2
The late incidence of POST
Timeframe: The late incidence will be assessed at 24 hours after surgery