FP15.01 Randomized Single-Blind Comparative Study of Midazolam Plus Pethidine Combination and Midazolam During Bronchoscopy

Abstract

Bronchoscopy is important in the diagnosis of lung cancer. It is often uncomfortable for the patients undergoing the examination. Although analgesia and sedation are important for tolerance of bronchoscopy, the optimal drug is not clear. We conducted a randomized, single-blind, comparative study to evaluate the efficacy and safety of midazolam/pethidine combination (combination group) compared with midazolam alone (midazolam group) as analgesia for bronchoscopy. we randomly assigned 100 patients who were scheduled to undergo bronchoscopy for biopsy of lung tumors or mediastinal tumors. 2mg midazolam and 17.5mg pethidine were given the combination group, and 2mg midazolam and placebo were given midazolam group intravenously before the start of bronchoscopy. Patients who were more than 75 yeas old or weighted less than 45 kg received half the dose. When the sedation level was considered shallow, we added 1 mg midazolam. The primary endpoint was the patients’ acceptance of re-examination assessed by visual analogue scale. The secondary endpoints were patients’ subjective symptoms, dose of drugs and safety. Table1Visual Analog Scale of patients’ subjective pain before and during bronchoscopyCombination groupMidazolam groupp. valueN=47N=49Q1. Did you have any concerns before the test?5.62±3.285.40±2.940.721Q2. Was the throat anesthesia you had before the test painful?3.92±2.943.86±2.740.907Q3. Do you remember what happened during the inspection?4.03±3.964.77±3.650.340Q4. Did you feel distressed during the examination?2.48±2.803.46±3.000.103Q5. Did you experience any pain during the bronchoscopy?1.10±1.882.13±2.42†0.022Q6. Did you have difficulty of breathing during the test?2.25±2.852.84±2.820.319Q7. Did you have a cough during the bronchoscopy?3.01±2.923.43±3.120.494Q8. Did you feel like the examination took a long time?3.69±2.393.61±2.320.869Q9. How are you feeling after the test?3.40±2.193.70±2.050.487Q10. Do you think you could have another bronchoscopy if necessary?3.82±2.934.17±2.750.547Q11. Do you think you could have another bronchoscopy if necessary? (yes or no)0.400Yes38 (80.9)35 (71.4)No9 (19.1)14 (28.6) Open table in a new tab Table 2Objective indicators and vital signsCombination groupMidazolam groupp. valueN=47N=49Examination time (minute)30.55±8.0834.73±7.71†0.011Initial dosage of midazolam (mg)1.77±0.431.69±0.470.432Number of additional administration of midazolam2.06±1.452.63±1.35†0.049Total dosage of midazolam (mg)3.83±1.564.27±1.340.145Total dosage of 2% xylocaine (mL)18.26±3.9719.70±3.670.076Maximal systolic blood pressure (mmHg)162.39±23.45178.24±30.24†0.005Highest heart rate (bpm)104.38±16.86105.59±17.810.734Lowest MOAA/S scale3.49±0.983.94±1.03†0.031Lowest oxygen saturation (%)92.13±3.2590.69±5.310.116Usage of flumazenil (%)0.983yes1 ( 2.1)0 ( 0.0)No46 (97.9)49 (100.0) Open table in a new tab Finally, we analyzed 47 patients in the combination group and 49 patients in the midazolam group. The acceptance score of re-examination was not significantly different between the two groups (3.82 vs. 4.17, p=0.547), but the visual analog scale score for physical pain was significantly lower in the combination group (Table1). Additionally the sedation level score during bronchoscopy, adverse events including maximal systolic blood pressure, the number of additional administrations of midazolam were significantly lower in the combination group (Table2). Our study has shown the efficacy and safety of the combination of midazolam plus pethidine method in the sedation for bronchoscopy. This combination method can improve tolerance of bronchoscopy.