Efficacy of a Dexmedetomidine-Remifentanil Combination Compared with a Midazolam-Remifentanil Combination for Conscious Sedation During Therapeutic Endoscopic Retrograde Cholangio-Pancreatography: A Prospective, Randomized, Single-Blinded Preliminary Trial.

BACKGROUND

Dexmedetomidine as a conscious sedative exhibits both analgesia and respiratory sparing effects.

AIMS

We evaluated and compared the sedative effect and the safety of a dexmedetomidine-remifentanil (DR) regimen with a midazolam-remifentanil (MR) combination during the endoscopic retrograde cholangio-pancreatography (ERCP) requiring conscious sedation.

METHODS

One-hundred and ninety-eight patients were randomized and divided into two groups. A bolus of midazolam (0.05 mg kg) was injected intravenously for MR group, and dexmedetomidine (1 μg kg) was pumping for 10 min for DR group. Next, an initial loading dose of 1 μg kg and 0.05-0.2 μg kg min of remifentanil was administered in all patients. Hemodynamic and respiratory changes, Ramsay Sedation Scale, Visual Analogue Scale, endoscopist and patient satisfaction were assessed. Furthermore, adverse events as well as recovery time and discharge time were rated.

RESULTS

Patient satisfaction scores were significantly higher in the DR group compared with MR group. The occurrence of desaturation was statistically higher, and the operation time was longer in the MR group. Although no statistically significant values could be determined between the two groups about amnesia and need of additional drug, the DR group was found to require a significantly reduced amount of extra midazolam. Furthermore, nausea during catheterization of oropharynx was found to be more pronounced in the DR group.

CONCLUSIONS

The dexmedetomidine-remifentanil protocol provided a parallel sedative efficacy and improved respiratory sparing effects. The higher patient satisfaction scores potentially offer a more reproducible ERCP quality. Adding dexmedetomidine to remifentanil can be used safely as a conscious sedation method during ERCP.