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Comparison of midazolam and dexmedetomidine as an adjuvant for proseal laryngeal mask airway insertion: A randomized control trial

Satveer Singh Gurjar

Department of Anesthesia, S.N Medical College, Jodhpur, Rajasthan, India

Babita

Department of Anesthesia, S.N Medical College, Jodhpur, Rajasthan, India

Kamlesh Kumar Sharma

Department of Anesthesia, S.N Medical College, Jodhpur, Rajasthan, India

RoncallBhim Raju

Senior Residence, AIIMS, New Delhi, India

BhupendraSingh

Department of Anesthesia, S.N Medical College, Jodhpur, Rajasthan, India

RakeshKarnawat

Department of Anesthesia, S.N Medical College, Jodhpur, Rajasthan, India

E-mail : drbabita24@gmail.com

DOI: 10.15761/GAPM.1000139

Article
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Abstract

Background

Proseal Laryngeal mask airway(PLMA), a modification of classical LMA, is safe and effective alternative airway device to endotracheal intubation. PLMA incorporates a drain tube ending at the tip so that there are less chances of aspiration. Use of muscle relaxant is not a must for PLMA insertion.

Methods

 100 patients of ASA grade I/II divided in two groups (50 in each group). Group A received inj. midazolam 0.03mg kg-1IV and group B received inj.dexmedetomidine0.4mcg kg-1.Induction was done with inj. propofol 2.5 mg/kg IV. Ease of PLMA insertion without using muscle relaxant was studded.  Time taken and number of insertion attempts, intraoperative haemodynamic parameters and complications were recorded.

Results

The resistance to mouth opening was significantly less(p=0.003) in the group B(significant resistance encountered in 2% cases) in compare togroup A (14% cases).The PLMA insertion conditions were better in group B compared to the group A (p<0.05). Time taken (11.48±3.34 sec)and number of attempts in PLMA insertion were significantly less (p<0.05) in group B when compare to group A (11.48±3.34 sec) without significant intraoperative haemodynamic changes except at 5th min post-insertion.

Conclusion

 Midazolam and dexmedetomidine both are acceptable in PLMA insertion. Dexmedetomidine produces better conditions for insertion of PLMA with greater haemodynamic stability and less postoperative complications as compared to midazolam.

Keywords

 proseal laryngeal mask airway, midazolam, dexmedetomidine, propofol

Introduction

The laryngeal mask airway (LMA)[1] has gained widespread popularity for airway management during surgery. Proseal Laryngeal mask airway(PLMA) is a modification of the classic laryngeal mask airway(CLMA) that incorporates a drain tube ending at the tip of the mask so that there are less chances of aspiration[2]. Use of muscle relaxant is not a must for PLMA insertion although a certain degree of jaw relaxation and depth of anaesthesia is required[3]. PLMA can be used as a safe and effective alternative airway device to endotracheal intubation [4].

Propofol is a useful agent for PLMA insertion because of its good jaw relaxation and suppression of the airway reflexes [5].

When used alone, the dose of propofol often exceeds 2.5mg/kg IV and easy insertion was seen only in about 62% of patients, and undesired side effects like drop in blood pressure, coughing, laryngospasm and body movement may occur [6]. We need an ideal agent or near ideal agent to overcome these side effects. A variety of adjuvant have been tried which can ease LMA insertion e.g. fentanyl [7], intravenous lignocaine[8], muscle relaxants [9] but none have been found to be ideal.

However, propofol is expensive so dexmedetomidine or midazolam used as anadjuvants to propofol may decrease the incidence of adverse responses to insertion of the LMA and cost. We considered that either of these drugs given before propofol may obtund airway reflexes sufficiently to allow satisfactory insertion of LMA at a lesser cost.

Midazolam and propofol both are known to act synergistically on gamma aminobutyric acid-A (GABA-A)recepters[10] and also reduces dose requirement[11].

Dexmedetomidine is a potent and highly selective α2adrenoreceptor agonist with a selectivity ratio of 1600:1(α21) and its premedication dose 0.33to 0.67 mcg kg-1 IV seems to be efficaciousand can be used as premedicationin LMA insertion [12-14].

The aim of this study was to compare Propofol plus Midazolam  orDexmedetomidine as an adjuvant  for the ease of PLMA insertion.

Methods

After institutional ethical committee approval a prospective randomized double blinded comparative study was conducted in Dr. S.N. Medical college and attached hospitals on 100 patients of   18-60 years age, 45-80 kg weight, BMI <25 and  ASA I & II status who were scheduled to undergo elective surgery. Patient having increased risk of aspiration (e.g. Gastro-oesophageal reflux disease, pregnancy), known or anticipated difficult airway, any history of reactive airway disease, surgery of the head and neck and allergy to any of the study drugs were excluded.

A detailed pre-anaesthetic check-up (PAC) including history, physical examination, detailed airway examination and routine investigations were carried out.

Patients were allocated into two groups by randomization using chit in box method. An anaesthetist who was not involved in PLMA insertion or assessment looked up the group assigned and prepared the drugs. The study groups were:

  1. Group A (n=50): Inj.Propofol 2.5 mg kg-1IV  with Inj.Midazolam  0.03mg kg-1 IV
  2. Group B(n=50): Inj.Propofol 2.5 mg kg-1IV  with Inj. Dexmedetomidine 0.4mcg kg-1 IV

After checking fasting status and written informed consent, an IV line secured with 18G cannula, all monitoring (ECG,pulse oximeter,Noninvasive arterial BP) attached and inj. Ringer Lactate started. Injglycopyrrolate 0.2mg IV was given 10 min before induction. The head was kept in sniffing position by using a firm 10 cm pillow. Patients were pre-oxygenated for 3 mins then given the study drug. Group A recievedInj. dexmedetomidine 0.4mcg kg-1 IV diluted in 20 ml normal saline over 5 min followed by NS 0.03ml/kgIV stat  and Group B given 20 ml NS over 5 min followed by Inj.Midazolam  0.03mg kg-1IV stat. After 2 min. inj. propofol 2.5 mg/kg IV administered over 60 seconds. To reduce pain on propofol administration 1ml of 1% lidocaine was added per 100 mg of propofol. If required further rescue doses of propofol 0.5mg/kg IV were given every 30 seconds until loss of verbal response and consciousness then PLMA was inserted after 60 sec of inj. Propofol. PLMA insertion was donebyexperienced anaesthetist.The sizes of PLMA were selected according to the patient weight. The PLMA was inserted according to standard protocol using the introducer tool technique.PLMA insertion conditions were assessed using six variables on a 3 point scaleas used by Singh R, et al. [15]as follows:

  1. Resistance to mouth opening
  2. Resistance to insertion
  3. Swallowing
  4. Coughing and gagging
  5. Head and body movement
  6. Laryngospasm (defined as a partial or complete obstruction with an apparently correctly placed PLMA)

Scoring system (Table 1) is a modification of muzi’s score [16]. A score of ≤12 in total ( or  ≤2 for each variable) were considered optimum for LMA insertion.

3 Point Scale

Variable

1

2

3

Resistance to mouth opening

Nil

Significant

Undue force required

Resistance to insertion

Nil

Significant

Undue force required

Swallowing

Nil

Significant

Undue force required

Coughing and gagging

Nil

Significant

Undue force required

Head and body movement

Nil

Significant

Undue force required

Laryngospasm

Nil

Significant

Undue force required

Total of all six variables

Range- min score 6 to max score 18

Table 1. Scoring system(muzi’s score).

The time taken for insertion was recorded from picking up the PLMA to the connection of breathing circuit. If the airway was found to be obstructed,PLMA was removed and another dose of propofol 0.5mg/kg was given, followed by another attempt of PLMA insertion 60 sec later.

A failed attempt was defined as removal of PLMA from the mouth. A maximum of two attempts were allowed and the number of attempts were recorded. After two failed attempts the study protocol was discontinued and the patient’s airway was managed according to standard protocols.

The PLMA placement was assessedby feeling the resistance at the end of device insertion, assessment of appropriate length of airway tube outside the mouth, outward movement of device on cuff inflation, neck bulge on cuff inflation, adequacy of manual ventilation, passage of gastric tube and supra-sternal notch test. No muscle relaxant is used in our study still if the patient remained apnoeic for more than 30 sec after PLMA insertion the lungs were manually ventilated until spontaneous ventilation returns.

After PLMA was successfully inserted, anaesthesiawas maintained with 1 vol%isoflurane and 60% N2O with 40% O2 and the end tidal CO2was maintained between 35-40 mmHg.

Each patient’s blood pressure and heart rate was recorded before and after giving the adjuvant drug and 1minute after induction with propofol and one minute after PLMA insertion and thereafter every minute till 5minutes post device insertion.

Any complication of device insertion like trauma to lip/tongue/oral mucosa, presence of blood on device, sore throat and difficulty on swallowing and pain on phonation after 1 hr post operatively was recorded.

Statistical analysis – Values are presented as mean (SD or range) or number (%). Hemodynamic data were analyzed using 2 ­tailed student's ‘t’­test for intergroup comparison and paired ‘t’ ­test for intragroup comparison. Ordinal categorical data such as LMA insertion conditions and number of attempts were analysed with the Chi Square Test. Nominal categorical data such as gender was also analysed with the Chi Square test. A p value < 0.05 was accepted as statistically significant.The statistical analysis was done using statistical package for the social sciences (SPSS) software version 17.0.

Results

All the data is expressed as mean and standard deviation. Demographic and airway examination variables were comparable and not significant in both groups. (p>0.05)(Table 2).

Variable

Group A

(Mean ± SD)

Group B (Mean ± SD)

P Value

Significance

Age Distribution

34.56 ± 10.09

38.16 ± 11.41

0.12

NS

Sex Distribution

M-40%

F-60%

M-42%,

F-58%

0.83

NS

Body Mass Index (BMI)

21.97 ± 0.54

21.98 ± 0.55

0.98

NS

ASA Status

ASA-I 76%

ASA-II 24%

ASA-I 70%

ASA-II 30%

0.54

NS

Modified Mallampatti

Grading

I- 46%

II-50%

III-4%

I-48%

II-52%

III-0%

0.55

NS

Inter-incisor distance assessment

4.2 ± 0.63

4.24 ± 0.57

0.76

NS

Baseline heart rate

89.52 ± 16.23

91.86 ± 14.79

0.48

NS

Baseline mean arterial pressure

90.71 ± 9.57

88.63 ± 6.89

0.31

NS

Table2.Demographic data and airway assessment.

Table 3 show LMA insertion conditions. The resistance to mouth opening was significantly more in group A with significant resistance in 14% cases (p=0.003) in compare to the group B (2%) and 98% had fully relaxed jaw in group B.

Group A

Group B

P value

Significance

Grading

Variable

Nil (%)

Significant (%)

Undue force required(%)

Nil (%)

Significant(%)

Undue force required(%)

Resistance to mouth opening

86

14

0

98

2

0

0.003

S

Resistance to PLMA insertion

94

6

0

94

6

0

0.65

S

Swallowing grading

84

16

0

92

8

0

0.36

NS

Grading of coughing and gagging

70

30

0

88

12

0

0.84

NS

Grading of head and body movement

56

42

2

86

14

0

0.02

S

Laryngospasm grading

100

0

0

100

0

0

Table3.LMA insertion conditions.

The incidence of head and body movement was significantly more in group A (p=0.02). Twenty one patients (42%) in group A had significant head and body movements in compare to only 7 patients (14%) in group B.

Although the incidence of swallowing in group A (16%) was more than group B (8%) but statistically insignificant.Similarly there was no significant difference among both groups in the incidence of resistance to PLMA insertion (p=0.65), incidence of swallowing (p=0.36), coughing and gagging (p=0.84) or laryngospasm (p=NA), but the incidence of all the above parameters is less in group B.

Table 4 show mean insertion score(Muzi’s score).There were statistically significant better PLMA insertion conditions in group B  compared to the group A when mean of all the six parameters(muzi’s score) were taken into consideration (p<0.05).

Muzi’s score

Group A

(Mean ± SD)

Group B

(Mean ± SD)

P value

Significance

Mean insertion score of 6 parameters

7.04 ± 1.08

6.38 ± 0.69

0.005

S

Table 4.Mean insertion score.

Table 5show ease of insertion.Time taken in PLMA insertion was significantly less (p<0.05) in group B (11.48±3.34 sec)when compare to group A (11.48±3.34 sec). Number of attempts to insert PLMA in group B were significantly less than groupA (p=0.02)

Variable

Group A Mean± SD

Group B Mean± SD

P Value

Significance

Time taken (in seconds) for PLMA insertion

14.86 ± 4.46

11.48 ± 3.34

0.003

S

Number of attempts

ONE- 84%

TWO-16%

ONE-98%

TWO-2%

0.02

S

Incidence of failure

12%

0%

0.54

NS

Contact with secretions of patient.

0%

0%

NA

NS

Table5.Ease of insertion.

Haemodynamicpapameters (Heart rate and MAP) at Pre-propofol, 1min after propofol,1 min, 2 min, 3 min, 4 min  after PLMA were comparable in both groups (Figure 1 and 2). But significant reduction in HR and MAP at 5 min after PLMAinsertion as shown in table6.

Variable

Group A Mean ± SD

Group B Mean± SD

P Value

Significance

Heart Rate

84.26 ± 14.74

78.06 ± 13.42

0.04

S

MAP

75.69 ± 9.22

71.28 ± 9.65

0.02

S

Table 6.Haemodynamic parameter at 5th min after PLMA.

Figure 1. Heart rate distribution.

Figure 2. mean arterial pressure distribution.

None of the patients showed any complication in group B and in group A one patient showed blood on PLMA and two patient complained sore throat (Table 7).

Group A

Group B

P value

Trauma n(%)

1(2)

0

NA

Blood on device n(%)

1(2)

0

NA

Sore throat n(%)

2(4)

0

NA

Difficulty swallowing n(%)

0

0

NA

Table7.Complications.

Discussion

LMA allows unobstructed airway and ventilation without the need to hold facemask or intubations.Classical LMA has certain advantages compared to endotracheal intubation such as haemodynamic stability at induction and emergence, reduced anaesthetic requirements for airway tolerance, lower frequency of coughing during emergence and a lower incidence of sore throat. The limitations are increased risk of gastric insufflation, gastro-oesophageal reflux and risk of aspiration of regurgitated gastric contents when using the CLMA [18,19].

Propofol is routinely used induction drug in the doses of 2 to 3 mg kg-1. Apart from adequate depth of anaesthesia, factors which affect LMA insertion are mouth opening, MMP grade of the patient, jaw relaxation and coughing.

Masahiroet al.[17] found that propofol alone at clinical dosage did not completely control responses to LMA insertion. Adjuvants like midazolam[11] or Dexmedetomidine[12] facilitate the insertion.

In our study both the groups were comparable with respect to the age(p=0.12), sex(p=0.83), BMI(p=0.98), and ASA grading(p=0.54), inter-incisor distance (p=0.76) and modified Mallampatti classification(p=0.55) and baseline hemodynamics.

Patel MG et al.[4] found full jaw relaxation in 93.3% of cases of PLMA insertion in unparalyzed patients using sevoflurane and oral midazolam in children. In our study group B had more number of fully relaxed jaw (98%) when compared to group A (84%).The result of six parameters of PLMA insertion in our study were similar to that found by HanciV et al.[26]although they studied the drugs for endotracheal intubation without muscle relaxant.

In our study mean score of all six variables was found to be significantly low (p<0.05) in group B (6.38±0.69) when compared to group A (7.04±1.08) which indicates that dexmedetomidine with propofol produced a significant improvement in PLMA insertion conditions.

The subjective smoothness of PLMA insertion was assessed either to be easy or difficult.The time taken for PLMA insertion and the number of attempts has been used as a parameter assessing the ease of PLMA insertion.Many investigators have studied the ease of insertion of LMA when using neuromuscular blockers[19,20,21]but  our study was done  without neuromuscular blockers.Brimacombeet al.[21]showed no difference between the two techniques. However, it cannot be assumed that use of muscle relaxants has no influence on the ease of insertion.

Lopez-Gil et al.[15] Brimacombeet al.[16]reported PLMA insertion time of 33 sec using propofol induction along with remifentanil with either digital or introducer tool technique. The mean time taken for PLMA insertion was significantly less (p=0.003) in group B (11.48±3.34sec) compared to group A (14.86±4.46sec) in our study. The time taken depends upon the criteria defining time interval, the operator, as well as the placement technique.

Evans et al.[22] have not shown significant differences in insertion success between digital and introducer techniques[21,22]. The introducer technique was chosen in all the patients included in our study for uniformity.

Brimacombe, Kelleret al.[23] found that using the insertion tool may require less time (15sec)to place PLMA with insertion tool in compare to digital insertion(23 sec) in study using neuromuscular blocker.

Brimacombeet al.[23] found that the first time success rate of PLMA insertion was 98% when using muscle relaxant. In our study the incidence of successful insertion of PLMA in the first attempt was 84% in group A and 98% in group B. However this difference was not statistically significant. In our study, there was no failure in group B, whereas there were four failures in group A. this might be due to the better ease of insertion seen in the group B but the result was statistically not significant.

Two manoeuvres were used in this study head tilt- chin lift and up-down manoeuvres. However, Jun et al.[24] found that the head position had no influence on the ease of PLMA insertion instead the head position can be selected according to individual patient’s position.

The baseline HR and MAP were comparable. Intraoperatively HR and MAP were comparable in both groups except at 5 minutes Post PLMA value where HR and MAP were significantly low in groupB (p<0.05). Similarly, Evanset al.[22] found a small reduction in heart rate at 5 min after PLMA insertion and significant decreases in mean arterial pressure at 1 and 5 min after PLMA insertion

None of the patients showed any postoperative complication in group B and in group A one patient showed blood on PLMA and two patient complained Sore throat. Cook et al.[25] found that the commonest complication was the presence of blood on PLMA on removal.               

Conclusion

We conclude that:

Both the drugs are acceptable for insertion of PLMA.

Use of dexmedetomidine (at dose of 0.04 mcg kg-1)produces better conditions for insertion of PLMA as compared to midazolam (at dose of 0.003 mg kg-1)

The sympathetic response to PLMA insertion is much low in patients who receiveddexmedetomidine-propofol in comparison with respect to patients whoreceived midazolam-propofol suggesting greater haemodynamic stability

Less incidence of post-operative complications in patients received dexmedetomidine.

References

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  9. Aghamohammadi, Eydi M, Hosseinzadeh H, AmiriRahimi M, Golzari SE (2013) Assessment of Mini-Dose Succinylcholine Effect on FacilitatingLaryngeal Mask Airway Insertion. JCardiovascThorac Res 5: 17–21. [Crossref]
  10. Krasowski MD, Hong X, Hopfinger AJ, Harrison NL (2002) 4D-QSAR analysis of a set of propofol analogues: mapping binding sites for an anaesthetic phenol on the GABA(A) receptor. J Med Chem 45:3210-3221. [Crossref]
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  12. Eren G, Cukurova Z, Demir G, Hergunsel O, Kozanhan B, et al. (2011) Comparison of dexmedetomidine and three different doses of midazolam in preoperative sedation. J AnaesthesiolClinPharmacol 27:367-372. [Crossref]
  13. Uzümcügil F, Canbay O, Celebi N, Karagoz AH, Ozgen S (2008) Comparison of dexmedetomidine-propofol vs. fentanyl-propofol for laryngeal mask insertion. Eur J Anaesthesiol 25:675-680. [Crossref]
  14. Ghatak T, Singh D, Kapoor R, Bogra J (2012) Effects of addition of ketamine, fentanyl and saline with Propofol induction on hemodynamics and laryngeal mask airway insertion conditions in oral clonidine premedicatedchildren.Saudi J Anaesth 6:140-144. [Crossref]
  15. Singh R, Arora M, Vajifdar H (2011) Randomized doubleblind comparison of ketaminepropofol and fentanylpropofol for the insertion of laryngeal mask airway in children.J AnaesthesiolClinPharmacol 27:91-96. [Crossref]
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Editorial Information

Publication history

Received date: December 05, 2015
Accepted date: January 19, 2016
Published date: January 22, 2016

Copyright

©2016Karnawat R. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Citation

Gurjar SS,Babita, Sharma KK, Raju RB, Singh B, Karnawat R(2016)Comparison of midazolam and dexmedetomidine as an adjuvant for proseal laryngeal mask airway insertion: A randomized control trial. Glob AnesthPerioper Med2: doi: 10.15761/GAPM.1000139

Corresponding author

RakeshKarnawat

Professor, Department of Anaesthesia and Critical Care, Dr. S. N. Medical College, Jodhpur, Rajasthan, India, Tel: 9828033321

E-mail : drbabita24@gmail.com

3 Point Scale

Variable

1

2

3

Resistance to mouth opening

Nil

Significant

Undue force required

Resistance to insertion

Nil

Significant

Undue force required

Swallowing

Nil

Significant

Undue force required

Coughing and gagging

Nil

Significant

Undue force required

Head and body movement

Nil

Significant

Undue force required

Laryngospasm

Nil

Significant

Undue force required

Total of all six variables

Range- min score 6 to max score 18

Table 1. Scoring system(muzi’s score).

Variable

Group A

(Mean ± SD)

Group B (Mean ± SD)

P Value

Significance

Age Distribution

34.56 ± 10.09

38.16 ± 11.41

0.12

NS

Sex Distribution

M-40%

F-60%

M-42%,

F-58%

0.83

NS

Body Mass Index (BMI)

21.97 ± 0.54

21.98 ± 0.55

0.98

NS

ASA Status

ASA-I 76%

ASA-II 24%

ASA-I 70%

ASA-II 30%

0.54

NS

Modified Mallampatti

Grading

I- 46%

II-50%

III-4%

I-48%

II-52%

III-0%

0.55

NS

Inter-incisor distance assessment

4.2 ± 0.63

4.24 ± 0.57

0.76

NS

Baseline heart rate

89.52 ± 16.23

91.86 ± 14.79

0.48

NS

Baseline mean arterial pressure

90.71 ± 9.57

88.63 ± 6.89

0.31

NS

Table2.Demographic data and airway assessment.

Group A

Group B

P value

Significance

Grading

Variable

Nil (%)

Significant (%)

Undue force required(%)

Nil (%)

Significant(%)

Undue force required(%)

Resistance to mouth opening

86

14

0

98

2

0

0.003

S

Resistance to PLMA insertion

94

6

0

94

6

0

0.65

S

Swallowing grading

84

16

0

92

8

0

0.36

NS

Grading of coughing and gagging

70

30

0

88

12

0

0.84

NS

Grading of head and body movement

56

42

2

86

14

0

0.02

S

Laryngospasm grading

100

0

0

100

0

0

Table3.LMA insertion conditions.

Muzi’s score

Group A

(Mean ± SD)

Group B

(Mean ± SD)

P value

Significance

Mean insertion score of 6 parameters

7.04 ± 1.08

6.38 ± 0.69

0.005

S

Table 4.Mean insertion score.

Variable

Group A Mean± SD

Group B Mean± SD

P Value

Significance

Time taken (in seconds) for PLMA insertion

14.86 ± 4.46

11.48 ± 3.34

0.003

S

Number of attempts

ONE- 84%

TWO-16%

ONE-98%

TWO-2%

0.02

S

Incidence of failure

12%

0%

0.54

NS

Contact with secretions of patient.

0%

0%

NA

NS

Table5.Ease of insertion.

Variable

Group A Mean ± SD

Group B Mean± SD

P Value

Significance

Heart Rate

84.26 ± 14.74

78.06 ± 13.42

0.04

S

MAP

75.69 ± 9.22

71.28 ± 9.65

0.02

S

Table 6.Haemodynamic parameter at 5th min after PLMA.

Group A

Group B

P value

Trauma n(%)

1(2)

0

NA

Blood on device n(%)

1(2)

0

NA

Sore throat n(%)

2(4)

0

NA

Difficulty swallowing n(%)

0

0

NA

Table7.Complications.

Figure 1. Heart rate distribution.

Figure 2. mean arterial pressure distribution.