Randomized Trial of Papaverine Hydrochloride to Prevent Vasospasm and Reduce Post‑operative Hypoparathyroidism in Adults Undergoing Total Thyroidectomy with Saline Control
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The study involves adults with benign or malignant thyroid disease who are undergoing a total thyroidectomy. This operation can sometimes cause arterial vasospasm, which is a sudden tightening of blood vessels, and a temporary loss of parathyroid function that leads to hypoparathyroidism, a condition where low hormone levels can reduce blood calcium. The trial tests whether applying the medication papaverine directly to the surgical site can reduce these problems compared with a control treatment of saline.
The purpose of the study is to determine if intra‑operative topical use of papaverine can lower the rate of transient hypoparathyroidism on the first day after surgery. Participants will be randomly assigned to receive either papaverine or saline during the operation, and they will stay in the hospital for routine monitoring. Blood samples will be taken the day after surgery to check calcium and parathyroid hormone levels, and the amount of fluid that drains from the neck will be recorded. Patients will be followed until discharge and later visits to see if any ongoing calcium or vitamin D supplements are needed.
The research process
The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
4 criteria
- Be 18 years old or older, but younger than 80 years.
- Have a thyroid condition that is either non‑cancerous (benign) or cancerous (malignant).
- Be scheduled to have a total thyroidectomy, which means the surgeon will remove the entire thyroid gland.
- Both men and women can take part in the study.
Who cannot join the trial?
8 criteria
- Inability to provide informed consent – you are unable to understand the study and agree to take part.
- Pregnant subjects – being pregnant (having a developing baby inside you) makes participation unsafe.
- History of drug addiction or alcoholism – past problems with drug or alcohol misuse that could affect safety.
- Serious neurological (brain or nerve), respiratory (lung), or cardiovascular (heart and blood vessels) diseases that contraindicate (make the surgery unsafe) or could cause the operation to take longer.
- Having had previous neck surgery – any earlier operation on the neck area.
- Presence of severe arthritis (joint inflammation) or osteoporosis of the spine (weak, fragile back bones).
- American Society of Anesthesiologists score >2 – a health rating before surgery that is higher than 2, indicating moderate to severe medical problems.
- Type III atrioventricular block – a specific heart rhythm disorder where electrical signals are delayed, affecting heart function.
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Trial locations
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Investigated drugs
What is already known about the treatment
Papaverine
Papaverine is applied directly to the surgical area as a topical solution during thyroid surgery. It is an established medicine that has been used for many years to relax smooth muscle and prevent blood vessel spasms, and many studies describe its effects. The drug works by blocking an enzyme called phosphodiesterase, which raises levels of a natural chemical (cAMP) that makes muscles relax. It is classified as a phosphodiesterase inhibitor and an antispasmodic vasodilator.
Saline
Saline is given as a topical drop of sterile salt water on the thyroid tissue, serving as a placebo in the trial. It is a standard, widely used medical fluid with a long history of safe use in many procedures. Saline does not contain an active drug; it simply provides a neutral, isotonic environment that does not affect blood vessels or hormone levels. It is classified as an isotonic crystalloid solution.
Investigated diseases
Benign thyroid disease
A condition where the thyroid gland develops non-cancerous growths, such as nodules or an enlarged gland (goiter). These growths may slowly increase in size over months or years. They usually do not spread to other parts of the body. The gland may produce normal, excess, or reduced thyroid hormones, affecting metabolism. Symptoms often develop gradually and may include a feeling of pressure in the neck.
Thyroid cancer
A malignant tumor that arises from cells of the thyroid gland. It typically grows slowly but can spread to nearby neck tissues and lymph nodes. Over time, the tumor may become larger and invade surrounding structures. Some types may produce excess thyroid hormones, while others do not affect hormone production. The disease may remain confined to the thyroid for years before spreading. Regular monitoring is needed to track changes in size and spread.
sourced from the EU Clinical Trials Register and site verification
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