A prospective evaluation of endoscopic ultrasound gallbladder drainage performed under conscious sedation. Which is better—ketamine, fentanyl, pethidine, or benzodiazepines?

Aims Endoscopic ultrasound-guided gallbladder drainage is usually reserved for high-risk surgical patients. This procedure is typically performed under deep sedation to ensure optimal patient comfort and facilitate the endoscopist’s performance. However, many patients exhibit high-risk factors even for deep sedation. Therefore, this study aimed to evaluate the safety and efficacy of EUS-GBD performed under conscious sedation (CS).

Methods All consecutive EUS-GBD procedures under CS performed at our hospital were prospectively enrolled from January 2020 to October 2024. Patient characteristics, type and dosage of sedative drug administered (Ketamine (KTM), Fentanyl (FNT), Pethidine (PTD) or Benzodiazepine (BZD)), the size of lumen-apposing-metal-stent (LAMS), gallbladder (GB) access, technical success, clinical success, early and late adverse events (AEs) rate were evaluated. Safety was defined as AEs occurrence. The efficacy of EUS-GBD was expressed as technical and clinical success. Conscious sedation was defined as “a drug-induced depression of consciousness during which patients respond to verbal commands or tactile stimuli, with intact breathing and no need for respiratory support.”

Results A total of 48 patients (42.1% male, mean age 82,9±10 years) underwent EUS-GBD under CS. In 44 (88.2%) EUS-GBD a 10x10mm LAMS was deployed, in 2 (5.9%) procedures a 15x10mm and in 2 (5.9%) an 8x8mm LAMS. GB was accessed from the stomach in 47.36% of cases. A combination of KTM+BZD was used in 14 cases (29.2%), while FNT+BZD was used in 17 cases (35.4%). PTD+BZD was used in 15 cases (31.2%), and BZD alone in 2 cases (4.2%). The mean doses of the sedatives were: KTM: 55.7±22.9 mg, FNT: 50±11.5 mcg, PTD: 38.4±25.6 mg and BZD: 4±1.5 mg. Technical and clinical success were 92.8% (13/14) and 100% for KTM+BZD, 100% and 100% for FNT+BZD, 93% (14/15) and 92.9% (13/14) for PTD+BZD, 100% and 100% for BZD alone, respectively. Overall technical and clinical success were 95.8% and 97.9%., respectively. Sedation related AEs were rare; 2 cases (4.2%) of respiratory insufficiency were reported (1 patient under FNT+BZD and 1 patient under PTD+BZD). No sedation related AE was reported in KTM+BZD group. Early AEs were observed in only 1 case (2%), while no late AEs were reported. The administration of KTM+BZD, FNT+BZD or PTD+BZD or only BZD affected neither technical nor clinical success. The AE rate between the different combination of sedative administered was not statistically significant (p=0.33).

Conclusions EUS-GBD under CS was a safe procedure with a low AEs rate. The administration of KTM+BZD, FNT+BZD, PTD+BZD or BZD alone did not affect procedure outcome and all sedation protocols were safe and effective.

Publication History

Article published online:
27 March 2025