A Randomized, Double-Blind Comparison of the Effects of Intravenous Midazolam Alone and in Combination with Meperidin On Hemodynamic and Respiratory Responses and On Patient Compliance During Upper Gastrointestinal Endoscopy

Abstract

Aim: We examined hemodynamic responses during examination of the upper gastrointestinal tract, monitoring blood pressure, heart rate and partial arterial oxygen saturation in healthy subjects and compared the changes with midazolam alone and in combination with meperidine. The aim of this study was to evaluate if either method has any advantages or disadvantages for patient compliance and for the commonly seen side-effects. Methods: Non-invasive baseline blood pressure measurements including systolic, diastolic and mean arterial blood pressures (SAP, DAP and MAP, respectively), heart rate (HR) and partial arterial oxygen saturation (SaO2) values were recorded by a blinded observer after topical anesthesia of the throat in patients scheduled for routine upper GI endoscopy (UGE). Either midazolam 0.05 mg/kg IV (Group I) or meperidin 0.3 mg/kg IV followed 1 min later by midazolam 0.05 mg/kg (Group II) IV were used for sedation. HR, SAP, DAP, MAP and SaO2 values were recorded before UGE, then at the 1 st minute and at 2 min intervals thereafter during the procedure. The endoscopists, who were also blinded for the type of medications used for sedation, assessed the comfort of patients according to pre-determined criteria. Statistical analysis was performed for both inter-group and in-group comparisons of parameters (baseline, after medication, 1 st min, 3 rd min and 5 th min values). Results: Thirty-patients in each group completed the study. No statistically significant difference of age was observed between the groups (p > 0.05). Heart rate increased significantly in Group I (p < 0.05). SAP, DAP, MAP and SpO2 decreased significantly with sedation in both groups during endoscopy (p < 0.05), but there was no significant difference between the groups for the changes in these parameters (p > 0.05). As for the criteria for scoring conditions at upper gastrointestinal endoscopy, patient compliance was significantly better in Group II than in Group I, for all measured criteria. Conclusion: Our findings revealed that heart rate increases significantly whereas SAP, DAP and SpO2 decreases significantly with both sedation methods and that there is no difference between the groups for these changes except for the significantly higher increase in heart rate in Group I. However patient compliance was significantly better when midazolam is used in combination with meperidine. We believe that use of combined sedation in selected patients will provide a safe sedation with a mild to moderate increase in heart rate and a better patient compliance during upper GI endoscopy.