|Year : 2020 | Volume
| Issue : 1 | Page : 38-43
The efficacy of dexmedetomidine and propofol for sedation in endoscopic ultrasonography: A comparative study
Apurva Jumle1, Vaibhav Mahajan1, Deepak Phalgune2, Ganesh Ghongate1, Nachiket Dubale3
1 Department of Anaesthesiology, Poona Hospital and Research Centre, Pune, Maharashtra, India
2 Department of Research, Poona Hospital and Research Centre, Pune, Maharashtra, India
3 Department of Gastroenterology (MED), Poona Hospital and Research Centre, Pune, Maharashtra, India
|Date of Submission||15-Nov-2019|
|Date of Decision||20-Nov-2019|
|Date of Acceptance||01-Dec-2019|
|Date of Web Publication||13-Feb-2020|
Dr. Deepak Phalgune
18/27, Bharat Kunj-1, Erandawane, Pune - 411 038, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Efficacy and safety of dexmedetomidine as a sedative agent has not been studied in a procedure such as endoscopic ultrasound (EUS) where propofol is being used extensively to provide a deep level of sedation. The present study was conducted to compare the efficacy of dexmedetomidine and propofol to achieve adequate sedation levels in patients undergoing EUS.
Methods: Sixty patients scheduled for EUS under sedation for the diagnostic and therapeutic purpose were randomly divided into two groups. Thirty patients in Group D received dexmedetomidine while 30 Group P patients received propofol. The recovery from sedation was assessed using the modified Aldrete's score. Once the modified Aldrete's score of 10/10 was achieved, the patients' perception regarding the pain was assessed using the Visual Analog Scale (VAS) score. Primary outcome measures were VAS score and vital parameters, whereas secondary outcome measures were gag reflex and recovery from sedation using the modified Aldrete's score. Comparison of quantitative and qualitative variables between the groups was done using unpaired Student's t-test and Chi-square test or Fisher's exact test, respectively.
Results: The absence of gag reflex was significantly higher in patients who received dexmedetomidine. Dexmedetomidine was found to have greater hemodynamic stability compared with propofol-treated patients. Dexmedetomidine achieved similar levels of sedation to propofol, although with a slower onset of sedation.
Conclusions: The use of dexmedetomidine was associated with greater hemodynamic stability and absence of gag reflex.
Keywords: Dexmedetomidine, endoscopic ultrasound, propofol, sedation
|How to cite this article:|
Jumle A, Mahajan V, Phalgune D, Ghongate G, Dubale N. The efficacy of dexmedetomidine and propofol for sedation in endoscopic ultrasonography: A comparative study. Indian Anaesth Forum 2020;21:38-43
|How to cite this URL:|
Jumle A, Mahajan V, Phalgune D, Ghongate G, Dubale N. The efficacy of dexmedetomidine and propofol for sedation in endoscopic ultrasonography: A comparative study. Indian Anaesth Forum [serial online] 2020 [cited 2020 Jul 5];21:38-43. Available from: http://www.theiaforum.org/text.asp?2020/21/1/38/278193
| Introduction|| |
Endoscopic ultrasound (EUS) has emerged over the past two decades as an important diagnostic and therapeutic tool for upper abdominal and lung pathologies. EUS is an invasive procedure in which endoscopy is combined with ultrasound to visualize the organs or the pathology adjacent to the gastrointestinal tract and is used routinely to diagnose esophageal, gastric, duodenal, pancreatic, and lung pathologies. The procedure can be extended as a therapeutic tool and usually takes 15–20 min.
The procedure may be performed with or without conscious sedation using topical pharyngeal anesthesia alone. However, patient's tolerance to the procedure and endoscopist's satisfaction are increased when sedation is used along with topical anesthesia. Patients undergoing unpleasant procedures such as EUS sedation contribute to better patient tolerance and compliance., Moreover, judicious use of sedation can alleviate the sympathetic response (rise in heart rate [HR] and systolic blood pressure) to the procedure. Sedation also reduces the danger of injuries during EUS due to inappropriate cooperation and facilitate the endoscopist's task.
The sedative agent of choice in EUS seems to be propofol due to its fast distribution and elimination time without a cumulative effect after infusion, resulting in shorter recovery time. Its therapeutic spectrum, however, is much narrower, and therefore, careful monitoring is much more demanding to differentiate between moderate, deep sedation and general anesthesia. The α2-receptor agonist, dexmedetomidine, has potent sedative properties., In addition, dexmedetomidine has analgesia-sparing properties.,,,,, At therapeutic doses, dexmedetomidine is not associated with respiratory depression despite profound levels of sedation., However, it is unknown if the autonomic effects of dexmedetomidine of decreasing sympathetic outflow might result in untoward hemodynamic effects when used for intraoperative sedation.,, Its efficacy and safety as a sedative agent has not been studied in a procedure like EUS where propofol is being used extensively to provide a deep level of sedation. The present study was conducted to compare the efficacy of dexmedetomidine and propofol to achieve adequate sedation levels in patients undergoing EUS.
| Methods|| |
This double-blind randomized controlled study was conducted between April 2018 and October 2018. After approval from the scientific advisory committee and institutional ethics committee, written informed consent was obtained from all patients. Patients aged 18–65 years scheduled for EUS under sedation for diagnostic and therapeutic purpose and belonging to the American Society of Anesthesiologist (ASA) Grade I and II were included in the study. Patients having 2nd or 3rd degree heart block, ejection fraction <30%, diseases affecting the central nervous system, psychiatric disorder, and body mass index (BMI) more than 30 kg/m2 and patients requiring conversion of sedation to general anesthesia were excluded from this study.
Of 73 patients assessed for eligibility, after the exclusion, 60 patients were randomly divided into two equal groups of 30 each, using computer-generated randomization code [Figure 1]. We used a sealed envelope for randomization with block size 4. Group D received dexmedetomidine, while Group P received propofol. This was done under the supervision of a senior staff nurse. Endoscopist and patients were blind as to their group assignment.
Detailed checkup was conducted 6–8 h prior to the procedure for anesthesia fitness. All patients were explained the Visual Analog Scale (VAS) method of reporting pain or discomfort and were told that they had to indicate postprocedure pain or discomfort in that manner. The recovery from sedation was assessed using the modified Aldrete's score. Once the modified Aldrete's score of 10/10 was achieved, the patients' perception regarding discomfort or pain was assessed using the VAS score.
Patients were made to lie supine on the procedure table. Intravenous (IV) access was confirmed and IV ringer lactate drip was started. Monitors were attached, and baseline parameters such as HR, noninvasive blood pressure, respiratory rate (RR), and peripheral oxygen saturation (SPO2) were noted down. After giving topical anesthesia with 10% lignocaine spray, the patient was asked to hold the mouth bite between upper and lower teeth. All patients received premedication 5 m before induction with IV midazolam (0.03 mg/kg) and IV fentanyl (2 μg/kg). In Group D, induction was done with an initial loading dose of dexmedetomidine (1 μg/kg) over 10 m period. Then, a maintenance infusion of 0.2–1.4 μg/kg/h (maximum rate of infusion up to 1.4 μg/kg/h) was started. In Group P, induction was done with an initial loading bolus dose of propofol (0.5–1.0 mg/kg) and subsequently given intermittently in a titrated manner as and when required. After the patient was adequately sedated, the endoscopist started the procedure. The presence or absence of gag reflex on passing endoscope was noted. Endoscopist's satisfaction was assessed by the absence of gag reflex. During the procedure, HR, Mean arterial pressure (MAP), SPO2, and RR were monitored and recorded. At the end of the procedure, the patient was shifted to the recovery room for observation. Postoperative assessment was carried out and modified Aldrete's score (0–10) was recorded at 0 m and at an interval of 5 m thereafter. VAS score for pain and alertness was recorded after the modified Aldrete's score of 10/10 was achieved. Any event of hypotension in the recovery room was treated initially with IV fluid bolus and then with a vasopressor (injection mephentermine 3 mg increments). Primary outcome measures were VAS score and vital parameters, whereas secondary outcome measures were gag reflex and recovery from sedation using the modified Aldrete's score. On the basis of a previously published study, a sample size of 30 patients in each group was calculated by a formula with 80% power and 5% probability of Type I error to reject the null hypothesis.
Data collected were entered into Excel 2007 and analysis of data was done using Statistical Package for the Social Sciences for Windows, Version 20.0 (IBM Corporation Armonk, NY, USA). The comparison of quantitative variables between the groups such as mean age, mean weight, mean height, mean BMI, mean time to achieve 10/10 modified Aldrete's score, mean HR, mean RR, mean SPO2, mean MAP, and mean VAS score was done using unpaired Student's t-test, whereas comparison of qualitative variables such as gender, ASA grade, patient's comfort, and endoscopist's comfort was done using the Chi-square test or Fisher's exact test. The confidence limit for significance was fixed at 95% level with P < 0.05.
| Results|| |
Of 73 patients assessed for eligibility, 13 were excluded because of BMI >30 kg/m2, ejection fraction <30%, and refused to participate. In this study, 60 adult patients undergoing EUS under sedation for the diagnostic and therapeutic purpose were randomly divided into two groups: propofol group (Group P) and dexmedetomidine group (Group D). There was no statistically significant difference between Group P and Group D in relation to mean weight, mean height, mean BMI, mean age, and ASA grades [Table 1].
Gag reflex suppression was significantly better in Group D. The distribution of mean time required to achieve the modified Aldrete's score of 10/10 differed significantly between the two study groups. Group D had significantly higher mean time required to achieve the modified Aldrete's score of 10/10. The distribution of mean postoperative VAS score and rates of complications did not differ significantly across the two study groups [Table 2].
The mean HR was significantly higher in Group P patients as compared to Group D patients from 5 to 30 min. There was no statistically significant difference between the two groups in relation to the mean MAP. The mean RR was significantly higher in Group P as compared to Group D at 25 and 30 min. RR was lower than the baseline value in both the groups. The mean SPO2 was significantly higher in Group D than Group P at 10, 15, and 30 min [Table 3].
| Discussion|| |
In the present study, after achieving modified Aldrete's Score of 10/10 in both the groups, the VAS score was studied. The mean VAS score did not differ significantly between the two study groups. Arain and Ebert reported that patients who received dexmedetomidine for sedation during the surgical procedure had significantly reduced pain scores and reduced analgesic needs (morphine) when compared with the propofol patients.
In our study, it was seen that the mean time in minutes to achieve modified Aldrete's score 10/10 postoperatively was higher in Group D (11.3 ± 3.3 m) as compared to Group P (6.2 ± 2.5 m). Arain and Ebert reported that propofol group patients achieved an Aldrete score of 9 in 28 ± 6 m, while dexmedetomidine group patients achieved it in 34 ± 7 m. They attributed this finding to the persistent effects of dexmedetomidine in the recovery room resulting in significantly more sedation when compared with the short-acting propofol.
On comparing the abolition of gag reflex among two groups in our study, it was found out that dexmedetomidine provided more favorable conditions for endoscopists to negotiate the endoscope through the oropharynx of the patient by blunting the upper airway reflexes as compared to propofol. Samson et al. reported that endoscopists expressed a higher level of satisfaction with dexmedetomidine compared with other sedatives.
One of the primary objectives of this study was to compare the hemodynamic changes in both the groups. In Group D, there was a fall in HR and MAP after giving the drug. The mean HR and mean MAP remained lower than their respective baseline values throughout the procedure. In Group P, there was no fall in HR seen after induction with propofol. The mean HR in Group P was higher than the baseline value during the procedure. There was a fall in the MAP after induction and remained lower than the baseline value throughout the procedure. In our study, it was found that compared to propofol, dexmedetomidine significantly reduced HR. Nishizawa et al. reported that dexmedetomidine significantly decreased the HR compared to propofol.
The previous study has demonstrated a powerful inhibitory effect of propofol on sympathetic outflow. Dexmedetomidine is also known to decrease sympathetic outflow and circulating catecholamine levels and would therefore be expected to cause decrease of MAP similar to those of propofol.,, The decrease in HR might be attributed to the sympatholytic effects and in part because of a vagal mimetic effect. Arain and Ebert observed that HR and MAP decreased after induction from baseline in both propofol and dexmedetomidine groups. Ghali et al., also found that both propofol and dexmedetomidine group of patients provided a similar significant reduction in HR and MAP compared with baseline values. However, in our study, it has been found that in the propofol group, HR remained above the baseline value throughout the study, whereas HR in dexmedetomidine group and MAP in both the groups remained lower than the baseline.
In our study, there was no significant fall in SPO2 observed after induction and at all points during the procedure from the baseline value in both the groups. However, during intergroup comparison, it was seen that the mean SPO2 in Group P was significantly lower at 10 and 15 min interval and postprocedure compared to the values at the same intervals in Group D. RR remained lower in both the groups (Group D and Group P) compared to the baseline value, respectively. During the intergroup comparison, the difference in RR was not statistically significant at all intervals except 25 and 30 m postprocedure. From the above observations, it is clear that the dexmedetomidine sedation maintained an adequate respiratory function as compared with propofol sedation. The SPO2 values of the dexmedetomidine group were significantly higher than those in the propofol group during the intraoperative period. Kaygusuz et al. reported similar findings that the RR values were significantly lower and the SpO2 values were significantly higher in the dexmedetomidine group compared with the propofol group.
De Sarro et al. reported that α-2 receptors are located at multiple places in the central nervous system. Hypercapnia activates the locus ceruleus, which is associated with increased apprehension and leads to the stimulation of the respiratory centers. Ebert et al. also reported similar results with dexmedetomidine sedation. On the other hand, Arain and Ebert reported similar respiratory endpoints between dexmedetomidine and propofol groups. This discrepancy in the results could be resulted from the difference in the regimen of drug infusion or the combination of narcotics. Sedative doses of propofol had been established to have minimal depressant effects on tidal-volume and minute ventilation, with end-tidal CO2 tension and arterial blood gas values remaining unchanged.
This study was conducted in a single center with a small sample size which included only stable ASA Class I or II patients. Therefore, our findings cannot be extrapolated to the patients with significant comorbidities. Our study excluded pediatric and geriatric population; hence, the safety and efficacy of dexmedetomidine in these age groups further needs to be studied. In our study, the endoscopic procedures were simple, diagnostic, and of short duration. Lengthy procedures are associated with more discomfort and retching as topical anesthetic applied once at the beginning of the procedure is short lived. Therefore, muticentric studies may be undertaken to compare the effectiveness of these agents involving patients undergoing lengthy procedures.
| Conclusions|| |
Suppression of gag reflex was significantly higher in patients who received dexmedetomidine. Dexmedetomidine was found to have greater hemodynamic stability compared with propofol-treated patients. Dexmedetomidine achieved similar levels of sedation to propofol, although with a slower onset of sedation.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]