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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 7  |  Issue : 1  |  Page : 111-116

The comparison of sedation quality of dexmedetomidine with midazolam using bispectral index and Ramsay sedation score in tympanoplasty under monitored anesthesia care


1 Department of Cardiovascular & Thoracic Anaesthesia, Seth G S Medical College & KEM Hospital, Mumbai, India
2 Department of Anaesthesiology and Pain Management, Jagjivanram Railway Hospital, Mumbai Central, India

Date of Submission23-Jan-2019
Date of Acceptance02-Dec-2019
Date of Web Publication16-Apr-2020

Correspondence Address:
Jitendra Homdas Ramteke
Department of Cardiovascular & Thoracic Anaesthesia, Seth G S Medical College & KEM Hospital, Mumbai
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/roaic.roaic_8_19

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  Abstract 

Background and aims Tympanoplasty is most commonly performed under local anesthesia supplemented with sedation. Midazolam is a commonly used drug in such procedures. Recently, dexmedetomidine is used for procedural sedation. We carried out a study to find whether dexmedetomidine is superior to midazolam in monitored anesthesia care in terms of sedation quality using bispectral index (BIS) and Ramsay sedation scale (RSS).
Patients and methods This randomized, prospective, single-blind study included 56 patients aged 18–50 years, equally divided into two groups. In group 1 (n=28), inj. dexmedetomidine 1 µg/kg over 10 min followed by infusion of 0.5 µg/kg/h was given. In group 2 (n=28), inj. midazolam 0.02 mg/kg intravenous followed by infusion of 0.01 mg/kg/h was given. Local anesthesia (2% lignocaine with adrenaline 1 : 200 000) was given by surgeon at the incision site. Inj. tramadol is used as rescue analgesia. Both groups were compared using BIS, RSS, hemodynamic parameters at regular time interval during surgery, and number of times rescue analgesia was required during surgery.
Results There is a significant decrease in heart rate after giving bolus dose in dexmedetomidine group. There was a significant difference of RSS in both groups at the time interval at RSS 4, RSS 5, and at RSS 6. There was a significant difference of BIS score in both groups at the time interval of BIS 4, BIS 5, and BIS 6. There was one patient who needed rescue tramadol in group 1, whereas in group 2, two patients needed rescue tramadol.
Conclusion We concluded that for monitored anesthesia care in surgeries like tympanoplasty performed under local anesthesia, inj. dexmedetomidine can be a better alternative over inj. midazolam with respect to sedation quality and fewer requirements of rescue analgesia. However, dexmedetomidine has an adverse event, that is, bradycardia, which can be manageable.

Keywords: bispectral index, dexmedetomidine, midazolam, Ramsay sedation scale, tympanoplasty


How to cite this article:
Upadhyay R, Ramteke JH, Sahu DK. The comparison of sedation quality of dexmedetomidine with midazolam using bispectral index and Ramsay sedation score in tympanoplasty under monitored anesthesia care. Res Opin Anesth Intensive Care 2020;7:111-6

How to cite this URL:
Upadhyay R, Ramteke JH, Sahu DK. The comparison of sedation quality of dexmedetomidine with midazolam using bispectral index and Ramsay sedation score in tympanoplasty under monitored anesthesia care. Res Opin Anesth Intensive Care [serial online] 2020 [cited 2020 May 31];7:111-6. Available from: http://www.roaic.eg.net/text.asp?2020/7/1/111/282594


  Introduction Top


Procedural sedation provides more comfort to the patient during painful or unpleasant diagnostic or therapeutic procedures. It may be preferred over general anesthesia owing to physiological, financial, and logistical considerations [1].

Midazolam has become the most frequently used medication given for sedation. Midazolam has a number of beneficial effects when used for sedation such as fast onset and limited duration of action. Despite having a number of beneficial effects, it is far from an ideal agent having untoward adverse effects, such as restlessness, paradoxical reaction, cognitive impairment, amnesia, and respiratory depression [2].

Dexmedetomidine is a selective α2 receptor agonist with properties of analgesia and sympatholysis without major respiratory depression. It reduces stress response to surgery, ensuring a stable hemodynamic state. Dexmedetomidine is increasingly used as a sedative for monitored anesthesia care (MAC) for various surgical procedures [3].

The need of the present study was to compare sedation qualities of dexmedetomidine with midazolam for MAC in tympanoplasty. In this study, we hypothesized that there is no difference in the sedation qualities of dexmedetomidine and midazolam. The primary objectives of the study were to compare bispectral index (BIS) [4] and Ramsay sedation scale (RSS) [5] for sedation using both the study drugs. The secondary objectives were to compare intraoperative hemodynamic parameters in both the study drugs, to compare the number of rescue analgesic doses required in both the study drugs, and to document any direct complications related to the drugs.


  Patients and methods Top


After approval by the institutional research and ethical committee of hospital, 56 adult patients posted for elective tympanoplasty surgeries receiving local anesthesia were enrolled in the study. Duration of study was one and half year (October 2015–March 2017). It was a prospective randomized single-blind comparative study.

Patients were equally divided into two groups as per randomization table taken from www.randomization.com. They were divided in two groups. In group 1, inj. dexmedetomidine, and in group 2, inj. midazolam was used for sedation. Patients fulfilling the inclusion and exclusion criteria were approached. Inclusion criteria were patients undergoing tympanoplasty surgery under local anesthesia, adult patients aged 18–50 years, patients with either sex, with American Society of Anesthesiologist (ASA) physical status I–II. Exclusion criteria were unwilling person, person with dementia or other mental/psychiatric symptoms, ASA grade III/IV, patients on pshychotropic medications, patients with known hypersensitivity to any of the study drugs, patients with history of sleep apnea, patients with asthma, and patient who needed general anesthesia.

Patients were explained about the operative procedure, sedation, RSS, and BIS. Informed consent was taken. After arrival in operation theater, patients were asked for their nil by mouth status for 6 h before surgery and started with maintenance fluid. With multichannel monitor, firstly baseline blood pressure, heart rate (HR), SpO2, and respiratory rate (RR) were recorded, and following medications were started: inj. glycopyrrolate 0.2 mg intravenous and inj. ondansetron 0.1 mg/kg. In group 1 (n=28), inj. dexmedetomidine 1 µg/kg over 10 min followed by infusion of 0.5 µg/kg/h was given. In group 2 (n=28), inj. midazolam 0.02 mg/kg intravenous followed by infusion of 0.01 mg/kg/h was given. Local anesthesia (2% lignocaine with adrenaline 1 : 200 000) was given by surgeon at the incision site.

Loading dose of tramadol 1 mg/kg intravenous was given in both groups and 50 mg as rescue analgesia in both the groups if RSS was less than 3. Additional amounts of tramadol were also recorded.

Surgery was started after the injection of the loading dose of study medication, and infusion of all study drugs was stopped at the end of the operation.

Observation

Intraoperatively, all the aforementioned hemodynamic parameters along with RSS and BIS via BIS monitor were recorded as follows:
  • Baseline (T0).
  • After bolus dose of tramadol (T1).
  • After loading dose of the study drug (T2).
  • At 10 min interval thereafter till the end of surgery (T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12).


Hemodynamic parameters and BIS and RSS were labeled according to the time interval, for example, BIS 1 is BIS at time interval T1.

The sample size was calculated based on mean and SD of earlier study [6]. By taking means of both groups, 80% power and 95% confidence interval, sample size was found to be 28 per group.

After data collection, data entry was done in Excel. Data analysis was done with the help of SPSS Software (Department of PSM, Nair Hospital Mumbai, Maharashtara, India), version 15 and Sigma Plot, version 12. Quantitative data variables were presented with the help of mean, SD, median, and interquartile range. Comparison among study group was done with the help of unpaired t test or Mann–Whitney test as per results of the normality tests. P value less than 0.05 was taken as significant level.


  Results Top


The two groups were similar with respect to age, BMI, ASA grading, and duration of surgery ([Table 1]). The effect on mean arterial pressure (MAP) was not found to be statistically significant. Thus, the two drugs had similar effect with respect to MAP.
Table 1 Comparison among study groups

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Mean HR2 (HR at time interval T2, i.e. after bolus dose of study drug) in group 1 was 77.36 (SD 13.26), whereas in group 2, the mean HR2 was 85.07 (SD 12.35). There was a significant difference in HR in both groups after giving bolus dose, that is, at HR2. There is a significant decrease in HR after giving bolus dose in dexmedetomidine group ([Figure 1]).
Figure 1 Heart rate at various time intervals in both groups.

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Mean RSS values at RSS 4, RSS 5, and RSS 6 were 3.50 (SD 0.839), 4.41 (SD 0.931), and 4.33 (SD 1.109), respectively, in group 1, whereas mean RSS values at RSS 4, RSS 5, and RSS 6 were 2.54 (SD 0.576), 2.50 (SD 0.509), and 2.70 (SD 0.823), respectively, in group 2. There was significant difference of RSS in both groups at time interval at RSS 4, RSS 5, and RSS 6 ([Figure 2] and [Table 2]).
Figure 2 Ramsay sedation score at various time intervals in both groups.

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Table 2 Comparison among study group for Ramsay sedation scale

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Mean BIS scores at BIS 4, BIS 5, and BIS 6 were 80.25 (SD 5.732), 76.96 (SD 8.951), and 75.30 (SD 8.844), respectively, in group 1, whereas mean BIS scores at BIS 4, BIS 5, and BIS 6 were 84.43 (SD 5.364), 81.79 (SD 4.298), and 80.11 (SD 5.124) in group 2. There was a significant difference in BIS score in both groups at time interval of BIS 4, BIS 5, and BIS 6 ([Figure 3] and [Table 3]).
Figure 3 Bispectral index at various time intervals in both groups.

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Table 3 Comparison among study group for bispectral index

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There were three patents who developed bradycardia in group 1, whereas in group 2, no patient developed bradycardia, but this was not statistically significant (P=0.075).

There was one patient who needed rescue tramadol in group 1, whereas in group 2, two patients needed rescue tramadol, but this was not statistically significant (P=0.553). There was one patient who developed prolonged sedation in group 1, whereas in group 2, no patient developed prolonged sedation, but this was not statistically significant (P=0.075). There was no significant difference in terms of saturation in both groups. There was no significant difference in terms of effect on RR in both groups.


  Discussion Top


Tympanoplasty surgery is usually done under local anesthesia with sedation under MAC or general anesthesia [3]. Patients may feel discomfort owing to pain and noise owing to suction, manipulation of instruments, and head-neck position [7]. There are many advantages of local anesthesia supplemented with intravenous sedation, such as less bleeding, cost-effectiveness, postoperative analgesia, faster mobilization of the patient, and the ability to test hearing intraoperatively [2].

Dexmedetomidine binds at α2 receptors rather than GABA receptors; this may explain the improved outcomes we and others have detected when comparing these two classes of medications. In addition to sedation, dexmedetomidine provides analgesic effects, a lack of respiratory depression, sympatholytic blunting of the stress response, preservation of neutrophil function (compared with the neutrophil-suppressing effect of GABA agonist medications), and may establish a more natural sleep-like state [8].

Traditional methods of assessing the level of sedation have relied primarily on subjective assessment of the patient and alteration of vital signs. Subjective assessments, however, are mostly based on speech and facial expression, which are often difficult to assess in a patient undergoing ocular procedures, as the drapes or surgery precludes observation and prevents the patient from responding.

The BIS monitor offers a distinct advantage of objective, real-time assessment of the sedated patient without the application of external stimuli [9].

This study was conducted in patients who were posted for tympanoplasty surgery under local anesthesia. MAC has important role in such surgeries. In this study, we compared sedation quality of dexmedetomidine with midazolam for MAC in tympanoplasty. We compared these two drugs with respect to BIS and RSS for sedation quality of these drugs, intraoperative hemodynamic parameters, number of rescue analgesic doses required in both the study drugs, and any direct complications related to the drugs.

Both the groups were similar in terms of age, sex, BMI, and duration of surgery. Thus, random distribution of patients was confirmed, and there were no confounding factors that would later interfere with the assessment.

In this study, effect of both the study drugs on MAP was found to be nonsignificant throughout the procedure. Previous studies [2],[10],[11] had similar results. However, in some studies [12],[13],[14],[15],[16], MAP is lower in dexmedetomidine group.

In this study, dexmedetomidine group had lower hear rate. Previous studies [2],[10],[11],[12],[13],[14],[15],[16] had the same effect on HR.

There was higher RSS in dexmedetomidine group. Previous studies [14],[15] had similar results.

In our study, BIS score is lower in dexmedetomidine group. Previous study [17] had similar result.

In this study, three patients developed bradycardia in dexmedetomidine group. Midazolam group required more recue analgesia. There was no significant difference in terms of saturation and RR in both groups.

Systemic review [1] also suggests dexmedetomidine is a promising alternative to midazolam for use in procedural sedation. Dexmedetomidine provides more comfort during the procedure for the patient and clinician. If carefully titrated, the safety profiles are similar.


  Conclusion Top


We concluded that for MAC in surgeries like tympanoplasty performed under local anesthesia, inj. dexmedetomidine can be a better alternative over inj. midazolam with respect to sedation quality and fewer requirements of rescue analgesia. However, dexmedetomidine has adverse event profile, that is, bradycardia, which can be managed by injection of atropine.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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Barends CR, Absalom A, van Minnen B, Vissink A, Visser A. Dexmedetomidine versus midazolam in procedural sedation. A systematic review of efficacy and safety. PLoS One 2017; 12:e169525.  Back to cited text no. 1
    
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Vyas D, Hihoriya N, Gadhavi R. RA comparative study of dexmedetomidine vs midazolam for sedation and hemodynamic changes during tympanoplasty and modified radical mastoidectomy. Int J Basic Clin Pharmacol 2013; 2:562–566.  Back to cited text no. 2
    
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    Figures

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  [Table 1], [Table 2], [Table 3]



 

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