Status:
NOT_YET_RECRUITING
Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy
Lead Sponsor:
Qianfoshan Hospital
Conditions:
Obesity
Gastrointestinal Endoscopy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Painless endoscopy is a popular method of endoscopic diagnosis and treatment. Propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and t...
Detailed Description
1\. The study population was recruited by the investigator participating in the clinical trial under the control of the principal investigator. 226 obese patients (30≤BMI≤40) who had undergone painles...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age 18-65 years
- 30≤BMI≤40
- Written informed consent of patient or family
- painless stomach + colonoscopy
- ASA grade I-II
- Exclusion Criteria：
- Patients with blood clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who cannot perform oropharyngeal airway ventilation;
- Severe cardiac insufficiency (≤4mets);
- Patients with severe renal insufficiency;
- diagnosed severe hepatic insufficiency;
- Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy;
- Increased intracranial pressure;
- Upper respiratory tract infections such as mouth, nose or throat;
- Fever (core body temperature ≥37.5℃);
- A confirmed diagnosis of pregnancy or breastfeeding;
- Allergic to sedatives such as propofol or equipment such as tape;
- Emergency surgery;
- Multiple trauma;
- SpO2 \< 95% before operation;
- A history of drug and/or alcohol abuse within 2 years prior to the start of the screening period;(Drinking more than three times standard alcoholic beverages per day, equivalent to about 10g of alcohol or equivalent to 50g of Chinese liquor);
- Patients with previous psychiatric and neurological diseases, such as depression, severe central nervous depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis;
- Currently participating in other clinical trials;
- Patients who are deemed unfit by the investigator to participate in the trial;
- Patients with a history of smoking were excluded
Exclusion
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT06590922
Start Date
October 1 2024
End Date
December 1 2025
Last Update
September 19 2024
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