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Randomized Controlled Trial
. 2017 Jul-Aug;49(4):304-311.
doi: 10.4103/ijp.IJP_683_16.

Comparison of midazolam with fentanyl-midazolam combination during flexible bronchoscopy: A randomized, double-blind, placebo-controlled study

Amithash Marulaiah Prabhudev  1 , Bharti Chogtu  2 , Rahul Magazine  1
Affiliations
Randomized Controlled Trial

Comparison of midazolam with fentanyl-midazolam combination during flexible bronchoscopy: A randomized, double-blind, placebo-controlled study

Amithash Marulaiah Prabhudev et al. Indian J Pharmacol. 2017 Jul-Aug.

Abstract

Background: Sedation during flexible bronchoscopy is desirable, but the drugs and the dosage protocols that are used vary.

Objective: To study and compare the effects of midazolam with fentanyl-midazolam combination during flexible bronchoscopy.

Materials and methods: The study was conducted on 144 patients, from October 2013 to July 2015. They answered Hospital Anxiety and Depression Scale-Anxiety subscale and a prebronchoscopy questionnaire to assess their expectation toward flexible bronchoscopy. The patients were randomized into three groups: placebo, midazolam, and fentanyl-midazolam. Vitals signs including heart rate, respiratory rate, blood pressure, and oxygen saturation (SpO2) were recorded. Furthermore, Ramsay Sedation Scale was assessed during the procedure. Primary outcome measure was the composite score of patient-reported tolerance and satisfaction (assessed after the procedure). Secondary outcome measures were composite score of physician-reported feasibility of the procedure, hemodynamic changes during bronchoscopy, and side effects.

Results: Patient-reported tolerance and satisfaction composite scores (median, interquartile range) for placebo, midazolam, and fentanyl-midazolam groups were 54 (52, 57), 59 (57, 61.5), 62 (58.5, 66), respectively; P < 0.001. Physician-reported feasibility composite scores (median, interquartile range) for the respective groups were 24.5 (20.5, 28), 25 (21, 27), 26 (25, 29); P = 0.004. There was no significant difference between the groups so far as mean heart rate (P = 0.305), mean systolic blood pressure (P = 0.532), mean diastolic blood pressure (P = 0.516), mean respiratory rate (P = 0.131), and mean SpO2 (P = 0.968) were concerned.

Conclusion: Conscious sedation with fentanyl and midazolam combination can result in better patient and operator satisfaction when compared with midazolam alone.

Keywords: Fentanyl; flexible bronchoscopy; midazolam.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
CONSORT flow diagram
Figure 2
Figure 2
Patient-reported tolerance and satisfaction composite score as per study groups (median, interquartile range)
Figure 3
Figure 3
Physician-reported feasibility composite score as per study groups (median, interquartile range)
See this image and copyright information in PMC

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