Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures

University of California Irvine (UCI)

Status and phase: Completed; Phase 4

Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP); Endoscopic Ultrasound (EUS)

Treatments: Drug: Promethazine; Drug: Diphenhydramine; Drug: Meperidine, Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT00937924

20075810

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Willing participants between 18 and 75 years of age who present for ERCP or EUS at H.H. Comprehensive Chao Digestive Disease Center.

Exclusion criteria

• History of allergic or adverse reactions to midazolam, diphenhydramine, or promethazine.
• Acute asthma, narrow angle glaucoma, concurrent use of potent inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir), pregnancy, or the inability to consent.
• Patients with conditions that preclude safe conscious sedation will be excluded.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

304 participants in 3 patient groups, including a placebo group

Meperidine and midazolam group

Placebo Comparator group

Description:

Control. Normal Saline Injections.

Treatment:

Drug: Meperidine, Midazolam

Meperidine and midazolam, plus Diphenhydramine group

Experimental group

Description:

Diphenhydramine injections given as adjunct sedative.

Treatment:

Drug: Meperidine, Midazolam

Drug: Diphenhydramine

Meperidine and midazolam, plus Promethazne group

Experimental group

Description:

Promethazine given as an adjunct sedative.

Treatment:

Drug: Meperidine, Midazolam

Drug: Promethazine