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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia | Active Comparator |
| |
| Deep sedation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tracheal intubation general anesthesia | Device | Endotracheal intubation with general anesthesia was administered to the patient during the ERCP procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative sedation related adverse events | Perioperative period |
| Measure | Description | Time Frame |
|---|---|---|
| recovery room time | Perioperative period | |
| Nasopharyngeal airway requires face mask ventilation or switching to tracheal intubation | Perioperative | |
| Second intubation after the tracheal intubation is removed |
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Inclusion criteria：
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaocui Lv | Contact | +8613567109477 | 3412008@zju.edu.cn | |
| Gang Chen | Contact | +8613757118681 | chengang120@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhijiang | 310016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41836944 | Derived | Lv X, Xu Y, Sun J, Liu H, Yu Y, Chen G. Effect of deep analgosedation vs. intubated general anesthesia on perioperative sedation-related adverse events in older adults undergoing ERCP: protocol for a randomized controlled trial. Front Med (Lausanne). 2026 Feb 26;13:1764649. doi: 10.3389/fmed.2026.1764649. eCollection 2026. |
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| Nasopharyngeal airway ventilation | Device | Nasopharyngeal airway-assisted deep sedation was employed for the patient during the ERCP procedure. |
|
| Perioperative |
| Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute) | Perioperative |
| Rating of reflux degree | perioperative |
| QoR-15 score on POD1 | Postoperative day 1 |
| Incidence of postoperative nausea and vomiting | postoperative day 1 |
| respiratory failure/ARDS incidence | Perioperative |
| Postoperative cognitive function assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) has a total score of 30 points, with a score of ≥26 considered normal | Perioperative |
| patient/endoscopist satisfaction | 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 | Perioperative |
| hospital stay duration | Perioperative |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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