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Cardiovascular sedation-related adverse events of General endotracheal anesthesia versus monitored anesthesia care during ERCP in patients with high risk of cardiovascular adverse events: a prospective, randomized, controlled trial

Cardiovascular sedation-related adverse events of General endotracheal anesthesia versus monitored anesthesia care during ERCP in patients with high risk of cardiovascular adverse events: a prospective, randomized, controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036906
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of the pancreas and the biliary tract

Interventions

MAC group:Intravenous anesthesia without endotracheal intubation
IGA group:general endotracheal anaesthesia

Sponsors

Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ERCP is planned, and the estimated operation time is >= 30min; 2. Sign informed consent; 3. Patients with one of the following cardiovascular risk factors: ASA >= grade 3; liver function child Pugh >= C; aged >= 75 years; weakness index >= 0.25; Bilirubin >= 50.

Exclusion criteria

Exclusion criteria: 1.STOP-BANG >= 3 points; 2.BMI >= 30; 3.Complicated with respiratory diseases (including asthma, COPD, ARDS, respiratory failure and respiratory tract infection); 4.Mask difficulty or airway difficulty is expected; 5.Satiety; 6.Tracheotomy; 7.Digestive tract obstruction; 8.Moderate and severe ascites (patients often have abdominal distension, positive mobile voiced sound, abdominal water submerges the intestinal canal under ultrasound, and the depth is > 3cm); 9.Hepatic encephalopathy.

Design outcomes

Primary

MeasureTime frame
incidence of composite SRCAEs;

Secondary

MeasureTime frame
incidence of SRRAEs;total procedure duration;room-in to room-out time in the ERCP suite;Number of body movements;Number of premature terminations due to sedation-related events;PACU resuscitation quality;Length of hospital stay;

Countries

China

Contacts

Public ContactJiangang Song

Department of Anesthesiology, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

songjg1993@126.com+86 13761172886

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026