RCT of Efficacy and Safety of Sedation Compared to General Anesthesia for ERCP : A Randomized Controlled Trial (RCT) of Efficacy and Safety of Sedation Compared to General Anesthesia for Endoscopic Retrograde Cholangio-pancreatography

What may be the benefits of general anaesthesia? In one retrospective study of more than 1000 patients, the ERCP failure rate with general anaesthesia was half compared to that observed with moderate sedation (7% versus 14%), with most failures resulting from inadequate sedation. It has also been reported that complication rates associated with therapeutic interventions during ERCP may be significantly lower when general anaesthesia is used, perhaps because the absence of patient movement makes the procedure technically less difficult. When general anaesthesia is administered for ERCP, the airway is protected by endotracheal intubation which may decrease risk for broncho-aspiration in some patients, although this measure has not been demonstrated to be effective in patients at risk during digestive endoscopy.However, aspiration at the time of in/ex-tubation as well as micro-aspiration of contaminated upper airway secretions along leaks and defects of the tracheal cuff seal is not excluded if standard endotracheal tubes are used.What may be the harms of general anaesthesia? Intubation and extubation manoeuvres may prolong endoscopic room occupation time, post-anaesthesia care unit stay may be longer and about 30 to 70% of patients will suffer from sore throat (this is reduced if lidocaine is used).Furthermore, orotracheal intubation may induce short time hemodynamic changes related to laryngoscopy.What may be the benefits of deep sedation? The main advantage of sedation is probably the faster turnover in the intervention room. In the sole practice survey of anesthesiologists for endoscopy that is available, 81% of anaesthesiologists stated that they were using sedation, not general anesthesia, for ERCP.Deep sedation with propofol during digestive endoscopy has been shown to be superior to moderate sedation with a combination of benzodiazepine plus opioid in many aspects, including better patient cooperation, shorter recovery time and lower number of desaturation events.In Switzerland, sedation during ERCP is obtained using benzodiazepines or propofol in similar proportions of cases and, when propofol is used, it is administered by the endoscopist or nurse in two thirds of cases and by the anaesthesiologist in one third of cases.Evidence from prospective studies suggests that complex procedures, including therapeutic ERCP, may be performed safely under deep sedation without tracheal intubation using propofol, even in high-risk patients.What may be harms of deep sedation? In a large study including nearly 10'000 patients, adverse events were observed in 1.4% of patients sedated using propofol. In that study, adverse events were defined as premature termination of the procedure due to sedation-related events (most often related to hypoxemia) or the need for assisted ventilation or, very rarely, admission to intensive care unit..

Medienart:	Klinische Studie

Erscheinungsjahr:	2023
Erschienen:	2023

Enthalten in:	ClinicalTrials.gov - (2023) vom: 15. Feb. Zur Gesamtaufnahme - year:2023

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Recruitment Status: Terminated Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: January 28, 2014, Last downloaded: ClinicalTrials.gov processed this data on February 22, 2023, Last updated: February 22, 2023

Study ID:	NCT02046590 B406201318623
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PPN (Katalog-ID):	CTG001595598