Nasal spray could replace pills for Pre-Surgery calm
NCT ID NCT07298525
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a nasal spray containing dexmedetomidine to help patients relax before surgery, even with minimal monitoring. Researchers will compare it to a placebo in 564 adults to see if it causes fewer breathing or heart problems. The goal is to find a safer, easier way to sedate patients before anesthesia.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 564 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * be 18 years of age or older, including the age of 18; no gender limitation; * American Society of Anesthesiologists (ASA) grade I to III; * Require general anesthesia, intraspinal anesthesia, or nerve block anesthesia for an elective surgical procedure; * Provide informed consent for participation in this study prior to the commencement of the trial and execute a written document of informed consent willingly. Exclusion Criteria: * Individuals with a known hypersensitivity to dexmedetomidine hydrochloride or any excipient; patients with a documented allergy to any tranquilizers, opioids, or other substances employed in the trial; * Individuals with airway hyperactivity, such as those suffering from chronic obstructive pulmonary disease (COPD), asthma, or sleep apnea, who are determined by the researchers to have experienced or are experiencing safety concerns related to these conditions; * Patients with a history of nasal disorders, previous surgical procedures, or allergic reactions deemed clinically significant by the research team, which could significantly impact drug absorption (e.g., chronic nasal congestion, rhinorrhea, nosebleeds, and other symptoms, as well as anatomical or mucosal abnormalities in the nose that may affect drug uptake); * A blood oxygen saturation (SpO2) level of less than or equal to 92% in a non-oxygenated state during the screening period; * patients with current psychiatric disorders (like schizophrenia or depression) or cognitive impairment; those with a history of epilepsy; or individuals with a past record of psychotropic or narcotic substance abuse; * A history of myocardial infarction or unstable angina pectoris within the past six months prior to the screening phase; * A heart rate or pulse rate of less than or equal to 50 beats per minute during the screening period, the presence of clinically significant heart functional abnormalities as determined by the investigators, or the presence of grade II or higher atrioventricular block (excluding patients with implanted pacemakers) along with other severe arrhythmias; * Patients with inadequately controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during the screening period) or hypotension (systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤ mmHg during the screening period); * Participants who have already engaged in other clinical trials and have taken the investigational drug within the three months preceding the screening period; * Pregnant or lactating women expected to undergo a cesarean section during labor and delivery; * The investigator concludes that the patient possesses other conditions rendering them ineligible for trial participation.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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