None
Conditions
Interventions
group D1:Dexmedetomidine hydrochloride nasal spray 50µg
group D2:Dexmedetomidine hydrochloride nasal spray100µg
group C:Placebo nasal spray
Sponsors
Sichuan Academy of Medical Sciences-Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The inclusion criteria for the first part of the study:The candidate for enrollment must satisfy all of the following criteria simultaneously: 1) be 18 years of age or older, including the age of 18; No gender limitation; 2)American Society of Anesthesiologists (ASA) grade I to III; 3) require general anesthesia, intraspinal anesthesia, or nerve block anesthesia for an elective surgical procedure; 4) provide informed consent for participation in this study prior to the commencement of the trial and execute a written document of informed consent willingly. The inclusion criteria for the second part of the study:The candidate for enrollment must satisfy all of the following criteria simultaneously: 1) be 18 years of age or older, including the age of 18; No gender limitation; 2)American Society of Anesthesiologists (ASA) grade I to III; 3) require general anesthesia, intraspinal anesthesia, or nerve block anesthesia for an elective surgical procedure; 4) The patient signs a written anesthesia informed consent form.
Exclusion criteria
Exclusion criteria: Part One Research on Exclusion Standards:1) 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; 2) 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); 3) 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; 4) Patients with current psychiatric disorders (like schizophrenia, depression), cognitive impairment; those with a history of epilepsy; or individuals with a past record of psychotropic or narcotic substance abuse; 5) A history of myocardial infarction or unstable angina pectoris within the past six months prior to the screening phase; 6) 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; 7) A blood oxygen saturation (SpO2) level of less than or equal to 92% in a non-oxygenated state during the screening period; 8) Patients with inadequately controlled hypertension (systolic blood pressure =160mmHg and/or diastolic blood pressure =100mmHg during the screening period) or hypotension (systolic blood pressure =90mmHg and/or diastolic blood pressure =50mmHg during the screening period); 9) Participants who have already engaged in other clinical trials and have taken the investigational drug within the three months preceding the screening period; 10) Pregnant or lactating women expected to undergo a cesarean section during labor and delivery; 11) The investigator concludes that the patient possesses other conditions rendering them ineligible for trial participation. Exclusion criteria for the second part of the study:1) Individuals who have demonstrated hypersensitivity reactions to dexmedetomidine hydrochloride or any excipient component; patients with a documented history of allergy to any sedative, opioid medication utilized in the study; 2) Women who are pregnant or lactating, including those who are anticipate pregnancy or are in the midst of childbirth, including those who have undergone a cesarean section; 3) The investigator determines that the patient possesses ailments other than those specified which, in the investigator's judgment, render the patient ineligible for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events in the circulatory and respiratory system requiring medical intervention;The incidence of clinically significant circulatory and respiratory adverse events determined by the researcher between medication and exit from the recovery room; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time from the end of the surgery to the first postoperative Aldrete score = 9;The incidence of circulatory and respiratory adverse events that require medical intervention as determined by researchers from the end of surgery to the exit of PACU;Ramsay score from initial administration to pre anesthesia;Incidence of POD;Postoperative patient and anesthesiologist satisfaction score;Total time between the end of the surgery to the departure from PACU;Postoperative patient and anesthesiologist satisfaction score; | — |
Countries
China
Contacts
Public ContactPeng Li
Sichuan Academy of Medical Sciences-Sichuan Provincial People's Hospital
Outcome results
None listed