Occurrence of hypoxemia in obese patients undergoing painless gastroenteroscopy
Conditions
Interventions
Control group:Administer an equal volume of intranasal normal saline
Test group:Nasal Spray Dexmedetomidine 100 µg
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range: outpatients or inpatients aged 18-65 years, regardless of gender; 2. Patients undergoing painless gastroscopy and colonoscopy. 3. Patients with ASA I-III; 4. Patients with body mass index (BMI) >= 28 kg/m²; 5. Patients who voluntarily participate in this study, sign a written informed consent form, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients allergic to dexmedetomidine hydrochloride or any component in the excipients; patients with a known history of allergy to any component in sedatives or opioids that may be used in the trial; 2. Patients with a nasal disease history, surgical history, or allergic history that is judged by the researcher to be clinically significant and severely affects drug absorption (such as having symptoms like long-term nasal congestion, runny nose, nosebleeds, abnormal nasal structure or nasal mucosa that affects drug absorption, etc.); 3. Patients with airway hyperreactivity, such as those with a past or current history of chronic obstructive pulmonary disease, asthma, pulmonary bulla, pulmonary embolism, pulmonary edema, etc., which are judged by the researcher to pose safety risks; 4. Patients currently suffering from mental system diseases (such as schizophrenia, depression, etc.), cognitive dysfunction; or patients with a history of epilepsy; or patients with a history of abuse of psychotropic drugs or anesthetics; 5. Patients with a history of myocardial infarction or unstable angina within 6 months before the screening period; 6.Patients with a heart rate or pulse = 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 <= 50 mmHg during the screening period); 8. Patients who participated in other clinical trials and used trial drugs within 3 months before the screening period; 9. Pregnant women during childbirth (including those scheduled for cesarean section) and lactating women; 10. Patients with a history of severe liver or kidney dysfunction; 11. Patients undergoing ESD (Endoscopic Submucosal Dissection).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Hypoxia During Surgery (75% <= SpO2 < 90%, Duration <= 60 Seconds); | — |
Secondary
| Measure | Time frame |
|---|---|
| During the surgical procedure, the incidence of subclinical respiratory depression (SpO? ranging from 90% to less than 95% for any duration) and severe hypoxia (SpO? < 75%, SpO? < 75% for more than 60 seconds, and SpO? ranging from 75% to less than 90% for more than 60 seconds) in cases with an Integrated Pulmonary Index (IPI) = 5, as well as the values of PETCO? and respiratory rate (RR) recorded by the IPI device, were collated and analyzed.;Sedative Effect;Total Dosage of Propofol;Hypotension (systolic blood pressure < 80 mmHg or systolic blood pressure decreased by more than 30% from baseline) and bradycardia (HR < 45 beats per minute);Patient Awakening Time;Records of the frequency of hypoxemia management and airway intervention, as well as the specific intervention methods;Drug Allergic Reaction;Satisfaction of Patients and Endoscopists;Follow up with patients every other day to inquire about and record whether they experience adverse reactions such as drowsiness, nausea, or dizziness after returning home post-surgery.;Record of Additional Analgesic Administration;Record of Additional Use of Nasopharyngeal Airways; | — |
Countries
China
Contacts
Public ContactShu Haihua
Guangdong Provincial People's Hosptial
Outcome results
None listed