Conditions: Endoscopic Ultrasound (EUS) Endoscopic Retrograde Cholangiopancreatography (ERCP)
Keywords: EUS ERCP Sedation Level Adverse Symptoms Recovery time
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 304
Healthy volunteers: yes

Brief summary:
The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.

Detailed description:
Comparing sedation techniques during invasive endoscopic procedures such as ERCP and EUS is a relatively unexplored area of clinical research. In particular, the effectiveness of adjunct sedatives such as diphenhydramine and promethazine during ERCP/EUS procedures has not been studied. Achieving a moderate sedation level may be ideal for ERCP/EUS procedures in order to provide adequate patient comfort, amnesia, and completion of intended endoscopic procedures. The relevance of further studies in this area is apparent. In terms of clinical practice; over-sedation can lead to decreased airway protection, longer post-procedural recovery times, and unnecessary drug cost; under-sedation can lead to patient anxiety, agitation, recall, and longer procedural time.

Arms:
arm 1: Control. Normal Saline Injections. arm 2: Diphenhydramine injections given as adjunct sedative. arm 3: Promethazine given as an adjunct sedative.

Interventions: intervention 1: Meperidine, Midazolam intervention 2: Diphenhydramine intervention 3: Promethazine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: