Endoscopic Ultrasonography, Monitoring, Sedation
Conditions
Brief summary
To meet the needs of both operators and patients, moderate and deep sedation has been widely used in digestive endoscopy, which is invasive and painful. With its pleasant effects, sedation has complications nevertheless. And respiratory depression is the most common one, which makes respiratory monitoring significant. SpO2 and respiratory motion are regularly monitored without satisfying timeliness or sensitivity. Capnography with current device is only able to detect either oral or nasal breathing. The present study was designed to test the effect of the investigator's modified End-Tidal Carbon Dioxide (ETCO2) monitoring device for sedation during endoscopic ultrasonography-guided fine needle aspiration.
Interventions
DEVICENovel end-tidal CO2 monitoring device
Apart from SpO2 and respiratory motion monitoring, the EtCO2 monitoring device is used to detect CO2 from nose and mouth simultaneously.
DEVICESpO2 and respiratory motion monitoring
Finger SpO2 and ECG-based respiratory motion monitoring are used during operation.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for ultrasonography-guided fine needle aspiration * Adult patients aged 18 to 65 years * American Society of Anesthesiologists (ASA) Physical Status Classification I-III * Subjects provide informed consent
Exclusion criteria
* Full stomach or upper gastrointestinal tract obstruction * Baseline pulse oximetric saturation (SpO2) \<95% while breathing room air * Obesity （BMI≥28kg/m2）or anticipated difficult airway * Cardiovascular or cerebrovascular events within 3 months * Pregnancy * Chronic opioid user * Allergic to anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral oxygen saturation | Across the sedation, assessed up to 2 hours | Peripheral oxygen saturation is measured by pulse oximetry and hypoxemia is defined as SpO2≤91% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The numbers of the times of body movement | From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours | The numbers of the times of any body movement across the procedure |
| Incidence of hypertension and hypotension | From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours | Hypertension or hypotension is defined as an increase or decrease in systolic blood pressure ≥20% compared to baseline values |
| Arterial pO2 and pCO2 | 30 minutes after initiation of the sedation | The results of arterial blood gas measurements including partial pressure of oxygen (pO₂) and carbon dioxide (pCO₂) |
| Total dosage of propofol | Across the sedation, assessed up to 2 hours | The patients are induced with 1.5\ 2.5mg/kg and maintained with 6\ 10mg/(kg•h) propofol. A propofol bolus dose range 0.2\ 0.5 mg/kg will be administered when needed. |
| Satisfaction score of the patients and endosonographers | Across the procedure, assessed up to 2 hours | Satisfaction score of the patients and endosonographers regarding to the sedation quality measured by a 0-100 visual analogue scale (VAS). 100 refers to the highest satisfaction degree while 0 refers to the worst satisfaction degree. |
| Recovery time | After termination of the sedation medication, assessed up to 2 hours | Duration of the recovery from sedation |
Countries
China
Contacts
Primary ContactJia-feng Wang, MD
Outcome results
None listed