Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection

Abstract

Aim: To compare the efficacy and safety of sedation protocols for endoscopic submucosal dissection (ESD) between dexmedetomidine-remifentanil and propofol-remifentanil.

Methods: Fifty-nine patients scheduled for ESD were randomly allocated into a dexmedetomidine-remifentanil (DR) group or a propofol-remifentanil (PR) group. To control patient anxiety, dexmedetomidine or propofol was infused to maintain a score of 4-5 on the Modified Observer's Assessment of Alertness/Sedation scale. Remifentanil was infused continuously at a rate of 6 μg/kg per hour in both groups. The ease of advancing the scope into the throat, gastric motility grading, and satisfaction of the endoscopist and patient were assessed. Hemodynamic variables and hypoxemic events were compared to evaluate patient safety.

Results: Demographic data were comparable between the groups. The hemodynamic variables and pulse oximetry values were stable during the procedure in both groups despite a lower heart rate in the DR group. No oxygen desaturation events occurred in either group. Although advancing the scope into the throat was easier in the PR group ("very easy" 24.1% vs 56.7%, P = 0.010), gastric motility was more suppressed in the DR group ("no + mild" 96.6% vs 73.3%, P = 0.013). The endoscopists felt that the procedure was more favorable in the DR group ("very good + good" 100% vs 86.7%, P = 0.042), whereas patient satisfaction scores were comparable between the groups. En bloc resection was performed 100% of the time in both groups, and the complete resection rate was 94.4% in the DR group and 100% in the PR group (P = 0.477).

Conclusion: The efficacy and safety of dexmedetomidine and remifentanil were comparable to propofol and remifentanil during ESD. However, the endoscopists favored dexmedetomidine perhaps due to lower gastric motility.

Trial registration: ClinicalTrials.gov NCT01920113.

Keywords: Dexmedetomidine; Efficacy; Endoscopic submucosal dissection; Peristalsis; Safety.

Figures

Figure 1

Changes of hemodynamic variables and SpO2 during endoscopic submucosal dissection. T0, just before the procedure; T1, 1 min after induction of sedation (1 min after a 5 min loading of dexmedetomidine in the DR group and 1 min after the propofol bolus injection in the PR group); T2, as the endoscope was passed into the esophagus; T3, as the endoscope marked the tumor region; T4, 5 min after epinephrine injection was given in the gastric submucosa; T5, at dissection of the gastric tumor region from the gastric submucosa; T6, once bleeding control was reached at the gastric bed; T7, and at the end of the procedure. HR: Heart rate; SpO2: Oxygen saturation; SBP: Systolic blood pressure; DBP: Diastolic blood pressure.