Biliary and Pancreatic Diseases, Endoscopic Retrograde Cholangiopancreatography (ERCP)
Conditions
Brief summary
This study aims to investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients.
Detailed description
This study aims to investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients.
Interventions
DEVICETracheal intubation general anesthesia
Endotracheal intubation with general anesthesia was administered to the patient during the ERCP procedure.
DEVICENasopharyngeal airway ventilation
Nasopharyngeal airway-assisted deep sedation was employed for the patient during the ERCP procedure.
Sponsors
Gang Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
： 1. Aged 60 and above; 2. ASA physical status≤III; 3. Patients who scheduled for elective therapeutic ERCP (ERCP complexity grading system; 4. Willing to provide informed consent (or by legal guardian/witness if applicable).
Exclusion criteria
： 1: Altered gastrointestinal anatomy, delayed gastric emptying, or gastric outlet obstruction； 2.Coagulopathy or epistaxis tendency; 3.Cardiac diseases (e.g., coronary artery disease, heart failure, arrhythmias); 4.Pulmonary diseases (e.g., asthma, COPD); 5.Prior hypersensitivity to anesthetic agents; 6.Active upper respiratory infection； 7.Severe liver and kidney diseases； 8.Difficult airway: Preoperative anesthesiologist assessment of difficult airway； 9.Psychiatric disorders, cognitive impairment, critical illness, or pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative sedation related adverse events | Perioperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasopharyngeal airway requires face mask ventilation or switching to tracheal intubation | Perioperative | — |
| Second intubation after the tracheal intubation is removed | Perioperative | — |
| Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute) | Perioperative | — |
| Rating of reflux degree | perioperative | — |
| QoR-15 score on POD1 | Postoperative day 1 | — |
| recovery room time | Perioperative period | — |
| respiratory failure/ARDS incidence | Perioperative | — |
| Postoperative cognitive function assessment (MoCA) | Perioperative | The Montreal Cognitive Assessment (MoCA) has a total score of 30 points, with a score of ≥26 considered normal |
| patient/endoscopist satisfaction | Perioperative | Patient/endoscopist satisfaction with sedation type was assessed using a 10-point visual analog scale (VAS), where 1 represented the worst possible experience and 10 indicated the optimal experience |
| hospital stay duration | Perioperative | — |
| Incidence of postoperative nausea and vomiting | postoperative day 1 | — |
Countries
China
Contacts
Primary ContactXiaocui Lv
Backup ContactGang Chen
Outcome results
None listed