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Table of Contents
ORIGINAL ARTICLE
Year : 2021  |  Volume : 5  |  Issue : 1  |  Page : 21-25

A comparative randomized clinical trial to assess the efficacy between dexmedetomidine and midazolam infusions for procedural sedation during septoplasty


1 Department of Anesthesiology, Mahatma Gandhi Medical College and Research Institute, Puducherry, India
2 Department of Critical Care Medicine, Mahatma Gandhi Medical College and Research Institute, Puducherry, India

Date of Submission30-Jul-2020
Date of Decision29-Sep-2020
Date of Acceptance20-Oct-2020
Date of Web Publication8-Feb-2021

Correspondence Address:
Dr. Sameera M Jahagirdar
Department of Critical Care Medicine, Mahatma Gandhi Medical College and Research Institute, Puducherry - 607 402
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/BJOA.BJOA_169_20

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  Abstract 


Background: Septoplasty is often performed under sedation with local anesthesia. Midazolam is one of the commonly used sedative but it lacks analgesic effect. Dexmedetomidine is now preferred, owing to the side effects of midazolam. However, there seems to be addressable literature void in this regard. This study was aimed to evaluate and compare the effectiveness of sedation between midazolam and dexmedetomidine infusions for procedural sedation during septoplasty under local anesthesia Patients and Methods: This was a randomized clinical trial involving sixty patients undertaking elective septoplasty under local anesthesia randomized into Group A that received intravenous dexmedetomidine 1 μg/kg over 10 min, followed by continuous infusion 0.5 μg/kg/h and Group B receiving intravenous midazolam 50 μg/kg (over 10 min), followed by continuous infusion 50 μg/kg/h. The Ramsay sedation score (RSS) and patient and surgeon satisfaction scores were documented. The analysis was done using the Chi-square test and Student t-test. Results: A significant change in the heart rate from 10 to 60 min was observed between the two groups (P < 0.05). The midazolam group showed a significant increase in mean arterial pressure (MAP) from baseline to 40 min time interval (P < 0.05). The respiratory rate remained constant in both groups. Patients attaining target RSS of 3–4 were significantly higher in the dexmedetomidine group (P < 0.05). Patient satisfaction score and surgeon satisfaction score were higher in the dexmedetomidine group (P < 0.05). Conclusion: Dexmedetomidine for septoplasty under local anesthesia is more effective than midazolam infusion in providing adequate sedation and provides stable hemodynamics and well-preserved respiratory functions.

Keywords: Arterial pressure, dexmedetomidine, heart rate, midazolam, respiratory rate


How to cite this article:
Sundar S, Jahagirdar SM, Hemanth Kumar V R, Krishnaveni N. A comparative randomized clinical trial to assess the efficacy between dexmedetomidine and midazolam infusions for procedural sedation during septoplasty. Bali J Anaesthesiol 2021;5:21-5

How to cite this URL:
Sundar S, Jahagirdar SM, Hemanth Kumar V R, Krishnaveni N. A comparative randomized clinical trial to assess the efficacy between dexmedetomidine and midazolam infusions for procedural sedation during septoplasty. Bali J Anaesthesiol [serial online] 2021 [cited 2021 Apr 22];5:21-5. Available from: https://www.bjoaonline.com/text.asp?2021/5/1/21/308885




  Introduction Top


Deviation of the nasal septum is one of the commonly noted scenarios in the general population and the cause for nasal obstruction causing dyspnea. Intervention by surgical means can be done under general anesthesia or local anesthesia with Monitored Anesthesia Care (MAC).[1]

The American Society of Anesthesiologists (ASA) defines MAC as “a planned anaesthesia procedure during which a diagnostic or therapeutic procedure is performed under local anaesthesia together with sedation and analgesia.”[1],[2] The essential components and role of MAC are safe sedation and control of anxiety. General anesthesia (GA) provides a safe airway throughout the surgery, allows the operator to perform the surgical procedure comfortably avoiding patient uncooperation.[2] Local anesthesia (LA), on the other hand, has the pros of not requiring intubation/mechanical ventilation, has less postprocedural adversities, but deems patient cooperation without anxiety. The sedation during LA ensures minimum anxiety and discomfort for patients. Drugs such as propofol, benzodiazepines, and opioids have been used for sedation during surgery under LA with MAC.[3]

Midazolam is the most frequently used sedative and has been reported to be well tolerated when used in LA under MAC. It is an imidazole-based benzodiazepine that has depressant effects on the central nervous system with rapid onset of action Adverse effects of midazolam include altered sensorium, respiratory depression, oxygen desaturation and confusion in elderly persons.[4]

Dexmedetomidine is a selective α2 receptor agonist with properties of sedoanalgesia, sympatholytic without major respiratory depression. This when used compensated the need for opioids and lowers the stress response to surgical procedure and presents a hemodynamic state.[5] The efficacy of the sedation is expressed in fixed dose of infusion that refers to the desired rate at which a drug should be administered to achieve a steady state of a fixed dose, which has been demonstrated to be therapeutically effective.[4],[6]

However, there has been a paucity of literature authenticating the efficacy of dexmedetomidine over midazolam. Therefore, the present study aimed to evaluate and compare the efficacy of sedation between dexmedetomidine and midazolam infusions for procedural sedation during septoplasty under local anesthesia and also to establish a sedation protocol using a fixed infusion dose of dexmedetomidine or midazolam.


  Patients and Methods Top


This was a randomized, double-blind, clinical trial conducted from January 2014 to April 2016 on 60 patients aged between 18 and 50 years. The institutional ethical committee (Registration no: ECR/451/Inst/PO/2013/RR-19) clearance (Approval no: PG/2014/05, date of approval: 08/01/2014) as well as prior informed consent from patients was obtained.

Patients with ASA physical status I–II and patients undergoing elective septoplasty under LA were included in the study. Patients with airway obstruction, obstructive sleep apnea, Mallampati Classes III and IV, obese, allergy to dexmedetomidine or midazolam, substance abusers, and medically compromised patients were excluded from the study.[7],[8]

Patients were randomly allocated into two groups by sealed envelope technique (Group A and Group B). Group A patients received loading dose of intravenous dexmedetomidine 1 μg/kg diluted in 20 ml of normal saline. Group B patients received loading dose of intravenous midazolam 50 μg/kg diluted in 20 ml normal saline.

The drug dosage was chosen based on patient body weight in accordance with manufacturer recommendations. To maintain the double-blind nature of the study, drugs were prepared by an anesthesia technician and diluted to a fixed volume of 20 ml. The anesthesiologist who gave the study drug and recorded data was also blinded to the patient group assignment.

Test solutions were diluted in a 20 ml syringe as total volume of 20 ml with normal saline. These syringes were labeled as “Loading” and “Maintenance” by the anesthesiologist. Group A patients received loading dose infused at a rate of 120 ml/h, followed by continuous infusion of 0.5 μg/kg/h diluted in 20 ml normal saline at a rate of 20 ml/h. Group B patients received loading dose at a rate of 120 ml/h, followed by continuous infusion of 50 μg/kg/h diluted in 20 ml normal saline at infusion rate of 20 ml/h. At the end of the loading dose and during the maintenance dose period, the patients were assessed every 10 minutes using Ramsay Sedation Score (RSS).[9],[10] The end of the loading dose was defined as 0 min.

The routine preoperative practice was employed for this study. All the patients were premedicated with oral ranitidine 150 mg and metoclopramide 10 mg on the night before surgery and on the morning of surgery. Standard ASA monitoring was applied. Fentanyl 1 μg/kg and intramuscular glycopyrrolate 0.2 mg were given to all patients 5 min before test drug infusion.

The target RSS score of 3 was considered as an adequate sedation level at the end of loading infusion. In case of over sedation before completing the loading dose, the infusion was stopped, and the study drug dose was noted. The test solution was restarted at RSS <3. The patients with RSS of <3 after loading drug administration, an intravenous fentanyl 10 μg boluses (maximum 5 repeat doses) were given to achieve targeted RSS.

The loading infusions in both the groups were followed by maintenance infusion. After the target sedation level was achieved, the surgeon infiltrated the LA (10 ml of 2% lidocaine with adrenaline). Intraoperative heart rate (HR), systolic blood pressure, diastolic blood pressure, oxygen saturation (SPO2), mean arterial blood pressure (MAP), and respiratory rate (RR) were recorded after the loading dose of the study drug and thereafter at 10-min intervals until the end of surgery. Sedation level (RSS) was assessed every 10 min and intravenous fentanyl 10 μg boluses were administered as a rescue analgesic in both groups for RSS <3 or the patient complained of pain. The total consumption of rescue doses of fentanyl during surgery was recorded. A maximum of five rescue doses (10 μg each) of fentanyl were allowed. Patients who did not tolerate the rescue measures were managed under GA and were removed as considered under exclusion criteria. The maintenance infusion was discontinued 10 min before the end of surgery.

Patients' cardiorespiratory parameters were monitored for 2 h in the recovery room. Intramuscular injection of diclofenac sodium 75 mg was given for postoperative pain relief. After monitoring and when no noted postoperative complications, patients were transferred to the specific ward. The primary outcomes were patient satisfaction and surgeon satisfaction scores that were evaluated using a numerical scale. The operating surgeon was asked to grade the patient cooperation during the procedure, satisfactory surgical field on a four-point scale (0 – not applicable: 1 – poor; 2 – fair; and 3 – good) based on similar assessment methods employed by Parikh et al. and Cheung et al.[11],[12] Surgeons' satisfaction is expressed as better patient cooperation during surgery, less bleeding from the surgical site, and good surgical field visibility.

Quality of sedation as measured with the Ramsay sedation scale, number of rescue doses of fentanyl, and respiratory and hemodynamic stability would have been better as primary outcome parameters. These are more objective measurements. Side effect profile, complications, and patient/surgeon satisfaction should have been secondary outcome parameters. They are largely subjective.

Data were analyzed using IBM, SPSS V 20, United states. Continuous variables were compared using Student's t-test. The categorical variables such as the demographic details and Ramsay sedation were evaluated using the Chi-square test. P < 0.05 was considered as statistically significant. The sample size was calculated using the two mean sample size, where the population variance was considered to be 1.1 based on the published literature.[6],[7]


  Results Top


The present study reveals that out of sixty patients, there were no dropped out cases [Figure 1]. There was no statistically significant difference between patient age, gender, weight, and duration of surgery [Table 1]. A significant difference of 10–60 min was observed in the HR between the two groups (P < 0.05) [Figure 2]a. There was no significant difference in baseline MAP between the two groups. The midazolam group showed a significant increase in MAP from baseline to 40 min time interval (P < 0.05). None of the patients developed hypertension or hypotension in both groups [Figure 2]b. RR and SpO2 were comparable between the two groups. There was no episode of desaturation and/or respiratory depression [Figure 2]c and [Figure 2]d.
Table 1: Association of demographics, American Society of Anesthesiologists grade, and duration of surgery between the groups

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Figure 1: CONSORT diagram

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Figure 2: Changes in (a) heart rate; (b) mean arterial pressure; (c) respiratory rate; (d) oxygen saturation

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The mean RSS between two groups at 10 min and 30 min showed significant changes [Table 2]. The midazolam group had increased fentanyl requirements than the dexmedetomidine group at various time intervals during the study. The total fentanyl requirement was significantly higher in the midazolam group (560 μg) compared to the dexmedetomidine group (140 μg) (P < 0.001) to maintain the target RSS level [Figure 3].
Table 2: Association of Ramsay sedation score over period in both the groups

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Figure 3: Total rescue fentanyl requirements

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Patients' and surgeon's satisfaction scores were significantly higher in the dexmedetomidine group than the midazolam group [Table 3].
Table 3: Association of patient satisfaction score and surgeon satisfaction score between groups

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  Discussion Top


The present study establishes the efficacy of sedation between fixed infusion doses of dexmedetomidine and midazolam so as to achieve satisfactory sedation levels for surgical procedures. A progressive increase in HR and MAP was seen in the midazolam group after local anesthetic infiltration. This can be attributed to the effect of adrenaline used in the local infiltration. The dexmedetomidine group showed stable HR and MAP related to the α2-agonistic effect. It was also observed that the HR and MAP remained stable for preoperative baseline values in the dexmedetomidine group. The findings were relatable to the study done by Karaaslan et al. and Parikh et al. who observed increased incidence of bradycardia and hypotension requiring immediate interventions in patients receiving midazolam.[11],[13]

The respiratory depression induced by sedatives like midazolam is mediated through the central gamma-aminobutyric acid receptor system. The respiratory depression becomes clinically evident as low-tidal volume and rapid RR with reduced SpO2. The current study showed no significant difference in RR and SpO2 between groups. The results obtained were contradictory to observations by Karaaslan et al. who stated that intergroup comparison showed a statistically significant reduction in SpO2 measurement after the loading dose administration in the midazolam group. Alhashemi observed a significant fall in SPO2 and an increase in RR in the midazolam group.[13],[14]

The ideal level of sedation with patient comfort and reduced cardiorespiratory effects were seen with RSS 3–4. Previous studies[11],[15] reported that the midazolam group required more rescue sedative to maintain sedation than the dexmedetomidine group. This can be attributed to the opioid sparing and analgesic properties of dexmedetomidine.

In the present study, both the groups received fentanyl as a rescue analgesic, which can cause respiratory depression. However, it was noted that the midazolam group had more fentanyl requirements than the dexmedetomidine group, which was similar to the findings of a study done by Akça et al.[16] Patients' satisfaction during the perioperative period under sedation is expressed as amnesia of the surgical events and comfort during surgery. In our study, the patient satisfaction-based score was more in Group A as reported by Cheung et al.[12] The plausible reason could be the analgesic property and the rapid weaning effect of sedation and recovery of psychomotor function from dexmedetomidine.

Surgeons' satisfaction is expressed as better patient cooperation during surgery, less bleeding from the surgical site, and good surgical field visibility. The findings had revealed better surgeon satisfaction scores in Group A than Group B similar to those reported by Parikh et al. who concluded better patient satisfaction score in Group A attributing to the quality of sedation.[11]

Midazolam has been used to provide sedation since ages but not without potential downsides. Hence, the novelty of the current study is its ability to establish the efficacy of dexmedetomidine over midazolam as a competent anesthesia technique for sedation and analgesia during septoplasty.

The current study has few limitations. First, a large multicentric study is needed for better assessment of the outcomes. Second, in this study, amnesia scoring and recovery of cognitive functions were not assessed, as the early discharge of the patients was not a concern of this study. Finally, only a sedation scoring system was considered. Therefore, further extensive investigation for a quantitative and objective assessment of the level of sedation focusing on the recovery of cognitive functions is needed.


  Conclusion Top


MAC with dexmedetomidine is an active anesthesia technique for sedation and analgesia during septoplasty. It causes diminished bleeding, nausea and vomiting, shorter recovery phase, more steady hemodynamic state, and higher satisfaction for both patient and surgeon.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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Parikh DA, Kolli SN, Karnik HS, Lele SS, Tendolkar BA. A prospective randomized double-blind study comparing dexmedetomidine vs. combination of midazolam-fentanyl for tympanoplasty surgery under monitored anesthesia care. J Anaesthesiol Clin Pharmacol 2013;29:173-8.  Back to cited text no. 11
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Karaaslan K, Yilmaz F, Gulcu N, Colak C, Sereflican M, Kocoglu H. Comparison of dexmedetomidine and midazolam for monitored anesthesia care combined with tramadol via patient-controlled analgesia in endoscopic nasal surgery: A prospective, randomized, double-blind, clinical study. Curr Ther Res Clin Exp 2007;68:69-81.  Back to cited text no. 13
    
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Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J 1974;2:656-9.  Back to cited text no. 15
    
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