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ORIGINAL ARTICLE
Year : 2023 | Volume
: 24
| Issue : 1 | Page : 36-42
Comparison of safety and efficacy of dexmedetomidine, midazolam and propofol for elective fiberoptic bronchoscopy: A randomised prospective double blind study
Priya Chouhan, Shruti Gupta, Anita Vig Kohli, Rajdeep Kour
Department of Anaesthesia, Government Medical College, Jammu, Jammu and Kashmir, India
Correspondence Address:
Dr. Rajdeep Kour
Department of Anaesthesia, Government Medical College, Jammu, Jammu and Kashmir
India
Source of Support: None, Conflict of Interest: None
CheckDOI: 10.4103/TheIAForum.TheIAForum_59_22
Background: Sedatives are used to improve the efficacy of fiberoptic bronchoscopy. This study was conducted to evaluate and compare the safety and efficacy of dexmedetomidine, midazolam, and propofol for elective fiberoptic bronchoscopy.
Materials and Methods: One hundred and twenty patients of either gender aged between 18 and 80 years, belonging to the American Society of Anesthesiologists Grade I–III and requiring fiberoptic bronchoscopy, were randomly assigned in three groups of 40 patients each. Patients in Group D received intravenous dexmedetomidine 1 μg/kg; in Group M, received IV midazolam 0.05 mg/kg; and in Group P, received IV propofol 1.5 mg/kg before the start of bronchoscopy. Parameters such as composite score, ease of bronchoscopy, and adverse effects during the procedure were assessed and analyzed statistically.
Results: Patients receiving dexmedetomidine showed significantly better tolerance and cooperation with ideal mean composite score compared to those receiving propofol and midazolam (P < 0.001). Bronchoscopist scoring showed significantly better ease of bronchoscopy in patients receiving dexmedetomidine compared to other two groups (P < 0.001). Adverse effects during the procedure were least in dexmedetomidine group compared to other two groups.
Conclusion: Dexmedetomidine (1 μg/kg) provided a better sedation and comfort, better bronchoscopist satisfaction, and least adverse effect during elective fiberoptic bronchoscopy compared to midazolam (0.05 mg/kg) and propofol (1.5 mg/kg).
Keywords: Dexmedetomidine, fiberoptic bronchoscopy, midazolam, propofol
Bronchoscopy is an endoscopic technique to visualize the inside of airway for diagnostic and therapeutic purposes. It may be either rigid or flexible. Fiberoptic bronchoscopy is usually done by respiratory physicians and is the gold standard for visualizing the airway and performing various diagnostic and therapeutic interventions.[1] Flexible fiberoptic bronchoscopy has replaced rigid bronchoscopy as a technique of choice for evaluation of the airway. It has advantages over rigid bronchoscopy such as reduced requirement of sedation, lesser complications related to the procedure, and better acceptability of the patient.[2]
The current guidelines for bronchoscopy recommend offering sedation for patient with the aim to improve patient comfort and cooperation and to reduce complications.[3] Studies conducted earlier have shown that bronchoscopy performed with sedation and without sedation were equally safe,[4],[5] but patient's comfort, tolerance to procedure, and repeatability increase clearly with the use of sedation.[6]
A variety of pharmacological agents such as benzodiazepines, opioids, and sympatholytic agents are used nowadays to blunt the response to bronchoscopy and to provide a better patient comfort during the procedure. Midazolam is the most commonly used benzodiazepine due to its short duration of action.[7],[8] However, dose-dependent respiratory depression, prolonged sedation, and cognitive disturbances may occur, especially in elderly patients and in those with comorbidities. Dexmedetomidine induces sedation and analgesia, but does not cause respiratory depression compared to other sedatives.[9] It also causes reduction in heart rate (HR) and blood pressure (BP), making it an attractive choice for sedation during fiberoptic bronchoscopy. Propofol is a sedative hypnotic with rapid onset of action and recovery, making it an appealing agent for procedural sedation.[10] Major limitations with the use of propofol are its narrow margin of safety between moderate sedation and deep sedation, unavailability of an antidote, and lack of analgesic property.
We are still using midazolam in our setup and it is a short-acting benzodiazepine, and fiberoptic bronchoscopy is also a short procedure, and many studies have not been done to compare the safety profile and efficacy of midazolam, propofol, and dexmedetomidine. Hence, we purpose to study the comparison of these drugs in terms of safety profile and efficacy during elective fiberoptic bronchoscopy. The primary objective was to compare sedation and comfort with dexmedetomidine, midazolam, and propofol during fiberoptic bronchoscopy. The secondary objective was to compare ease of insertion and adverse effect during and after the procedure.
Materials and MethodsAfter getting approval from the Institutional Ethics Committee (IEC/GMC/2020/05) and informed written consent from patients, 120 patients of either gender, aged between 18 and 80 years, belonging to the American Society of Anesthesiologists (ASA) Grade I–III and requiring fiberoptic bronchoscopy for 1 year (November 2019–March 2020), were included in this prospective randomized study. They were randomly allocated to one of the three groups of 40 each: group D, Group M, and Group P based on a computer-generated randomization list. Exclusion criteria included patient's refusal, patient with known or suspected allergy to any of the study group, severe chronic obstructive pulmonary disease, patients having cognitive or psychotic disorder, and hemodynamic instability (bradycardia HR <50 bpm or hypotension systolic BP [SBP] <90 mmHg) [Figure 1].
All patients were kept fasting 6 h before the procedure. Tablet alprazolam 0.25 mg was given night before the procedure. Intravenous (IV) access was established. IV pantoprazole 40 mg, IV ondansetron 0.1 mg/kg, intramuscular (IM) diclofenac 1.5 mg/kg, and IM glycopyrrolate 3 μg/kg were given 30 min before the procedure. Two drops of oxymetazoline were administered into each nostril half an hour before the procedure. Patients were made to do gargles with xylocaine viscous (2%) before entering the operation theater. In the preoperative room, baseline parameters such as noninvasive BP (NIBP), HR, and oxygen saturation (SPO2) were measured. After receiving patients in the operating room, all routine monitors such as electrocardiogram, NIBP, and pulse oximeter were attached. Supplemental oxygen at 4 L/min through the nasal cannula was provided to all patients, and in case of fall in SPO2 during the procedure, the flow was increased accordingly. On operation table, lidocaine spray was sprayed on the posterior wall of the pharynx (each actuation delivering 7.5 mg of lidocaine) before administering the study drug. Randomization was adhered for selection of patients using a random number list into each one of the three groups to receive either of the following drugs. All drugs were prepared in 10 ml identical syringes by an independent anesthesiologist not involved further in the study. Patients and the principal investigator were unaware of the group allocation and followed the blinding protocol; also the arm of patient was screened so that bronchoscopist could not see the study drugs. Patients in Group D received IV dexmedetomidine 1 μg/kg for 10 min; in group M, received IV midazolam 0.05 mg/kg for 2 min; and in Group P, received IV propofol 1.5 mg/kg for 5 min before the start of bronchoscopy. Bronchoscope was inserted at the end of giving the study drug.
After administering the study drug, 2% lignocaine jelly was applied to the patient's nostril, following which fiberoptic bronchoscope was passed through the nostril. Vocal cords, trachea, and bronchus were sprayed with 2 ml of 2% lignocaine solution by spray-as-you-go technique till tertiary segment has reached where evaluation and procedure for which patient was scheduled were completed. In the event of patient turning uncomfortable or restless during the procedure after topicalization of airway, IV propofol 0.5 mg/kg was administered as a rescue medication in all the three groups.
Patient's response to bronchoscopy was assessed using composite score by Goneppanavar et al.[11] consisting five different parameters, i.e., sedation, calmness, respiratory response, physical movement, and facial tension. Each parameter was given a score of 1–5. It was recorded during bronchoscopy. For clinical and statistical purposes, the composite score [Table 1] was considered: Ideal: 5–10; Acceptable: 11–15, and Unacceptable: >15. Bronchoscopist (who remained same in all patients) was asked regarding the ease of bronchoscopy, and he classified it as easy, slightly difficult, or difficult. Any episode of hypoxemia (SPO2 <90% for >30 s), hypotension (SBP <90 mmHg), hypertension (SBP >180 mmHg or diastolic BP >100 mmHg), tachycardia (HR >100/min and/or variation >20% from baseline value), bradycardia (HR <50 beats/min), need for mandibular support, manual ventilation, intubation, and need to abandon the procedure was recorded.
Sample size calculation
A pilot study was done that included nine patients, three patients in each group, that is, Group D, Group M, and Group P. The mean composite score was 9.32 ± 1.93 in Group D, 14.80 ± 1.67 in Group M, and 13.9 ± 2.24 in Group P. The result of pilot study showed a composite score difference of 3 between Group D and Group M, and difference of 2 between Groups D and P; whereas composite score difference between Group P and Group M was 1. Hence, on the basis of this pilot survey, we estimated that 40 patients were needed in each group to have a power of 80% and 95% confidence interval and 0.3 effect size. Hence, we included a total of 120 patients in our study.
Statistical analysis
Categorical variables were presented in number and percentage (%), and continuous variables were presented as mean ± standard deviation and median. Normality of data was tested by the Kolmogorov–Smirnov test. If the normality was rejected, then nonparametric test was used. Quantitative variables were compared using the Mann–Whitney test (as the datasets were not normally distributed) between the two groups and the Kruskal–Wallis test between three groups. Qualitative variables were compared during the Chi-square test/Fisher's exact test (P < 0.05 was considered statistically significant). The data were entered in MS Excel spreadsheet, and analysis was done using the Statistical Package for the Social Sciences (IBM SPSS) version 21.0.
ResultsA total of 120 patients (40 in each group) were enrolled in our study, and all of them completed the study. In our study, all the three groups were comparable in patient demographics, i.e., age, gender, ASA grading, and weight with no statistically significant difference [Table 2]. Composite score was acceptable in 4 (10%) patients, ideal in 36 (90%) patients, and unacceptable in none in Group D, while it was acceptable in 37 (92.50%) patients, ideal in none, and unacceptable in 3 (7.50%) patients in Group M. In Group P, it was acceptable in 32 (80%) patients, ideal in 2 (5%) patients, and unacceptable in 6 (15%) patients. The mean score was 8.52 ± 1.63 in Group D, 14.05 ± 1.28 in Group M, and 13.4 ± 1.97 in Group P [Table 3]. Our observations are statistically significant when Group D was compared to M and P, while it was statistically insignificant when Groups M and P were compared. Hence, it was found that the mean composite score of Group D was ideal showing a better patient tolerance and cooperation compared to Groups P and M.
Table 2: Comparison of demographic profile between groups dexmedetomidine, midazolam, and propofol
Table 3: Comparison of composite score between groups dexmedetomidine, midazolam, and propofolEase of bronchoscopy was assessed by the bronchoscopist. It was observed that the intergroup comparison between the three groups was statistically significant with Group D showing better ease of bronchoscopy, followed by group P; while in Group M, the bronchoscopist experienced most difficulty [Table 4].
Table 4: Comparison of ease of bronchoscopy between groups dexmedetomidine, midazolam, and propofolGroup D has least episodes of tachycardia and hypertension, followed by Group P; while in Group M, there were highest hypertensive and tachycardia episodes. These findings were statistically significant. Hypotension and bradycardia developed in 1 (2.50%) patient in Group D and none in Groups M and P (not statistically significant). Patients receiving dexmedetomidine had least episodes of hypoxemia during the procedure, while Group P had highest episodes of hypoxemia (statistically significant). Need for mandibular support was highest in Group P, followed by Group M, and least in Group D (statistically significant). Manual ventilation was needed in 3 (7.50%) patients in Group P, but this observation was not statistically significant. None of the patient in all the three study groups required intubation [Table 5].
Table 5: Comparison of side effects between groups dexmedetomidine, midazolam, and propofol during the procedure Discussion Flexible bronchoscopy is a key procedure for the diagnosis and treatment of pulmonary disease and is commonly performed in clinical practice. Stress during bronchoscopy can cause release of catecholamines, which has adverse effects such as tachycardia, vasoconstriction, and possible myocardial ischemia in patients with impaired cardiopulmonary function. The current guidelines for bronchoscopy recommend offering sedation for patients with the aim of improving patient comfort and cooperation and to reduce complications.
Various pharmacological agents such as benzodiazepines, opioids, and sympatholytic agents are used nowadays to blunt the response to bronchoscopy and to provide a better patient comfort. However, not many studies are done to determine the efficacy and safety of midazolam, propofol, and dexmedetomidine. Hence, the current study was done with the aim to compare the safety and efficacy of dexmedetomidine, midazolam, and propofol sedation for elective fiberoptic bronchoscopy. The primary objective was to compare sedation and comfort with dexmedetomidine, midazolam, and propofol during fiberoptic bronchoscopy. The secondary objective was to compare ease of insertion and adverse effect during and after the procedure. In our study, we evaluated the patients using several parameters that included composite score, hemodynamic, ease of bronchoscopy, and adverse effects.
Our observation showed that patients receiving dexmedetomidine had ideal mean composite score with a better patient tolerance, cooperation, and better level of sedation compared to patients receiving midazolam and propofol. Further, ease of bronchoscopy was assessed by the same bronchoscopist in all the patients; there was better ease of bronchoscopy in patients receiving dexmedetomidine compared to patients receiving propofol; while in patients receiving midazolam, the bronchoscopist experienced most difficulty. All the results were statistically significant. Our study was in accordance to the study done by Goneppanavar et al.,[11] where the mean composite score was acceptable in midazolam group and ideal in dexmedetomidine group. Furthermore, they showed that bronchoscopy was considered easy in maximum number of patients receiving dexmedetomidine compared to patients in group midazolam. Similar results were observed in study conducted by Wu et al.,[12] where dexmedetomidine, propofol, and fentanyl combination shows a higher safety with a fewer procedural interference and higher bronchoscopist satisfaction than midazolam, propofol, and fentanyl combination.
Hemodynamic response to bronchoscopy was also evaluated. Patients receiving dexmedetomidine had a better hemodynamic stability during bronchoscopy, followed by the patients receiving propofol; while in midazolam group, there were highest hypertension and tachycardia episodes. Hypotension and bradycardia developed in one (2.50%) patient who received dexmedetomidine and none in patients received midazolam and propofol. These findings were statistically significant and in accordance to study done by Shoukry,[13] which showed that respiratory stability and hemodynamic response to insertion of fiberoptic bronchoscopy throughout the procedure were significantly lower in dexmedetomidine group than group propofol. Another study done by Liao et al.,[14] where patients sedated with dexmedetomidine, displayed a fewer sympathetic responses to bronchoscopy compared to those sedated with midazolam.
Patients receiving dexmedetomidine had least episodes of hypoxemia during the procedure, whereas patients receiving propofol had highest episodes of hypoxemia which got relieved by procedure requiring verbal/tactile stimulation to maintain the airway. These findings were statistically significant. The need for mandibular support was highest in patients receiving propofol compared to other groups (statistically significant). Manual ventilation was needed in 3 (7.50%) patients receiving propofol, but this observation was not statistically significant. None of the patient in all the three study groups required intubation. Our results are in accordance to study done by Yuan et al.,[15] where hypoxemia was significantly lower in dexmedetomidine-fentanyl compared to propofol-fentanyl group. It is also in accordance to study done by Shoukry,[13] where desaturation (due to apnea, airway obstruction needing mask ventilation) occurred more frequently in propofol-fentanyl group compared to dexmedetomidine group. Similar findings were observed in study done by Dey S et al.[16] where the incidence of airway obstruction and transient hypoxia was significantly lower in patients receiving intravenous dexmedetomidine as compared to those receiving intravenous propofol for sedation in elective awake fiberoptic intubation.
A meta-analysis of randomised controlled studies done by Wang Z et al.[17] concluded that propofol sedation shows similar safety compared with midazolam sedation during bronchoscopy.
Strength and limitations
The strength of our study was that we were able to ensure blinding of the individual performing bronchoscopy. Second, the dose of drugs we used for sedation was appropriate. Third, bronchoscopist was same in all patients, so results regarding ease of bronchoscopy were better assessed. Whereas the limitation of our study was the small sample size, and we did not collect any data on rescue doses of propofol given in each group. This calls for similar studies with a larger sample size for a better evidence provision.
ConclusionIn our study, we concluded that IV dexmedetomidine (1 μg/kg) provided a better sedation and comfort, better bronchoscopist satisfaction, and least adverse effect during elective fiberoptic bronchoscopy compared to IV midazolam (0.05 mg/kg) and IV propofol (1.5 mg/kg). Hence, we suggest that dexmedetomidine can be adopted as a standard sedation regimen for patients undergoing flexible bronchoscopy for a greater safety and improved efficiency.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
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