Study to Determine if the Midazolam-Meperidine-Dexmedetomidine is Superior to the Midazolam-Meperidine for Sedation During ERCP

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) takes a longer time and is more complex to perform than the other parallel procedures, causing discomfort to patients. It is commonly performed under sedation endoscopy. Until recently, the combination administration of midazolam and opioid has been widely used as standard therapy due to its superior sedation effect compared to the other sedation agents. Midazolam, however, has problems, such as an insufficient sedation effect and an intermittent paradoxical response.

Unlike midazolam, propofol has no antagonist and may cause problems such as respiratory depression, and has a narrow therapeutic range for the sedation effect, consequently requiring supervision by experienced experts, although it has a better sedation effect than midazolam. Due to these disadvantages, propofol is clinically less useful than midazolam.

Meanwhile, dexmedetomidine, a selective α2 adrenergic agonist, is known to maintain the proper level of sedation and has a weak influence on respiratory depression. Recent studies have shown positive results with dexmedetomidine in relation with the sedation effect for surgery patients under local anesthesia or in intensive care units.

As such, extensive studies are being conducted on the use of dexmedetomidine in endoscopic procedures due to the increased attention to dexmedetomidine. This notwithstanding, the clinical usefulness of dexmedetomidine is still debatable. In particular, studies on the use of dexmedetomidine for ERCP are very rare.

Given the recent idea that dexmedetomidine may exert a synergistic effect in combination with midazolam, these authors endeavored to prospectively compare and analyze the sedation effect and adverse events, including respiratory depression, of the combination therapy of midazolam and meperidine, both of which have been widely used in patients undergoing ERCP, and of the combination therapy of midazolam, meperidine, and dexmedetomidine.

The small-scale comparative study on the combination administration of propofol and fentanyl, which has a high risk of causing complications, and on the single administration of dexmedetomidine is the only study on the sedation effect of dexmedetomidine in the ERCP procedure that has yet been conducted; there has been no study that investigated the effect of the combination administration of dexmedetomidine and other drugs in the ERCP procedure. This study is thus expected to contribute to the development of guidelines on sedation in the ERCP procedure.

Conditions

• Undergoing ERCP for Diagnostic or Therapeutic Purposes

Interventions

DRUG

Dexmedetomidine

dexmedetomidine 1μg/Kg•hr IV continuous infusion, initiated 15 min before the procedure (ERCP) till complete procedure

OTHER

normal saline

0.9% NaCl 1μg/Kg•hr IV continuous infusion, initiated 15 min before the procedure (ERCP) till complete procedure

Sponsors & Collaborators

• Hana Pharm Co., Ltd.

  collaborator INDUSTRY

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Sang Hyub Lee, M.D. Ph.D · Assistant Professor of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital

• Ban Seok Lee, M.D. · Fellowship doctor, Division of Gastroenterology, Department of Internal Medicine, Seoul National University Bundang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2012-03-31

Completion

2012-03-31

Countries

• South Korea

Study Locations