Pub 3
Pub 3
Pub 3
14196
Original Article
Debashish Paul1, Kaminder Bir Kaur2, Arijit Ray3, Alok Jaiswal4, Shreyas Kate5, Anshu Mala Bhengra6
hospital ethics committee (IEC 72| 2017 dated 23 May 2017) and titrated accordingly. Once the procedure was over, patients were
written, informed parents consent. shifted out to the recovery room following discontinuation of the
Children between the age groups six month to six years in American study drug infusion.
society anaesthesiologist category (ASA) I and II undergoing elective The time period from the discontinuation of the study drug infusion
diagnostic MRI were included in the study. to spontaneous eye opening and recorded modified Aldrate score
Children having congenital heart disease, history of (H/O) upper of 10/10 of the patient in the recovery room followed by the time
respiratory tract infection, pneumonia or episode of acute severe to discharge from the Post-Anesthesia Care Unit (PACU) were
asthma in the preceding four weeks, H/O recent use of digoxin, recorded.
alpha 2-agonist or psychotropic medications were excluded from Circulation was judged by HR instead of BP. The time intervals from
the study. Also, children with H/O allergies to the study drugs PACU discharge were determined.
predicted, anatomical difficult airway and procedures taking time of
less than 45 minutes were excluded from the study. STATISTICAL ANALYSIS
Total 74 patients were registered for the study. Two groups were For the purpose of sample size calculation, the statisitically significant
decided as Group “K” for children receiving Ketamine and Group difference in the time of onset of sedation between the two groups, a
“D” for children receiving DEX. Group allocation was done randomly previous study was referred to [13]. To detect an observed difference
based on the odd and even number of the reporting date for pre of 20% in between the groups, with a power of study 80% and a
anaesthetic check-up in the Institution. Allocation of patients to type I error of 0.05, the minimum sample size required was 26 in
either group was done by a clinician not involved in the study and each group. Total number of allocation of patients in various groups
same was kept concealed until data collection and analysis were were kept more than 30, assuming a drop out of 10% patients.
completed. All children were allowed to take clear liquids up to two Nominal data (number of subjects with apnoea, saturation and rescue
hour before sedation but food (including breast milk) intake was with
medication etc.,) were presented as number (n) and percentage (%).
held as per standard guideline for Nil Per Os. (NPO)
Continuous variables (e.g., age, weight, HR, RR etc.,) were expressed
Baseline values were recorded for all children upon arrival in the as mean (Mean) and Standard Deviation (±SD). Chi-Square test was
preparation room in the MRI suite. A 22G (gauge/size) or 24G applied for comparison of nominal data. For continuous variable,
venous cannula was inserted in the dorsum of the hand which was unpaired t-test was applied to compare between groups. Paired
prepared one hour prior with the application of the Eutectic Mixture t-test was applied to compare within group findings (Pre Vs Post).
of Lignocaine and Prilocaine (EMLA) cream. If the procedure was Additional parametric as well as nonparametric analysis of the data
delayed IV fluids was administered as per maintenance rate in the was performed as deemed essential. The p-value of <0.05 was
pre-anaesthesia care unit at the MRI suite. considered as statistically significant. The analysis of the data was
A loading dose of DEX (1 mcg/kg was given over 10 min) or ketamine performed using Microsoft excel and Statistical Package for Social
(1 mg/kg) with glycopyrrolate 10 mcg/kg) was given intravenously Sciences (SPSS) (software version 13.0).
(IV) followed by continuous infusion of DEX (0.2-0.7 mcg/kg /h) in
Group D or ketamine (10-15 mcg/kg/min) in Group K. RESULTS
Response to sound, verbal commands or tactile stimulation were A total of 61 patients were analysed in the present study, 31
evaluated and sedation level of children was measured after every in Group K and 30 children in Group D [Table/Fig-1]. Both the
10 minutes with the help of Ramsay sedation scale [12]. groups were comparable in demographical distribution and the
diagnosis for which an MRI was undertaken [Table/Fig-2]. Bilateral
The Ramsay scale assigns a score of 1-6 based on the clinical
Sensorineural Hearing Loss (SNHL) and seizure disorder were the
assessment of the level of sedation (1=anxious, agitated, restless;
most common diagnoses in both the groups [Table/Fig-3]. HR
2=awake, but cooperative, tranquil, orientated; 3=responds to
and RR in both the groups prior to start of sedation (at 00 min)
verbal commands only). Scores 4-6 apply to sleeping patients and
were comparable and not statistically significant. During sedation
are graded according to the response to loud noise or a glabellar
a decrease in both HR and RR from baseline was observed in
tap (4=brisk response; 5=sluggish response; 6=no response).
both the groups. However, this decrease in both HR and RR
The children were taken into the MRI suite when reflecting stable when compared between the two groups were not statistically
haemodynamic and respiratory parameters with a Ramsay sedation significant [Table/Fig-4].
score of five. Time starting from drug infusion till achieving Ramsay
score of five is defined as onset of sedation.
If a Ramsay score of six was not achieved after 15 minutes of study
drug infusion to the maximum dose determined in the study protocol
or inadequate sedation occurred during MRI examination, a single
rescue dose of midazolam 0.1 mg/kg IV was administered (to a
maximum of 3 mg by titration) to the patients in both the groups.
Inadequate sedation was defined as difficulty in achieving the
desired level of sedation and not able to complete the procedure
because of movement during MRI examination. HR, SpO2 and
RR were monitored continuously and recorded at 5-minutes
intervals during the study period by the observer inside the
MRI suite. All patients were maintained on spontaneous
respiration with a target SpO2>90%. Oxygenation was done
via a transparent face mask fitted adequately. If there was a
drop in SpO2 below 90% for 30 seconds, patient was taken
out of the MRI tunnel and target SpO2 was achieved by various
techniques of maintaining airway patency, titration of oxygen
flow and with the help of airway adjuncts. Once settled down,
the procedure was continued and the study drug infusion was [Table/Fig-1]: Flow diagram of patient distribution.
Group K (n=31) Group D (n=30) 00-05 Min 20.97 2.98 19.93 2.85 0.18
Significance
Parameter Mean SD Mean SD (p-value) 00 Min 22.43 2.86 21.80 3.93 0.47
Age (years) 4.64 3.16 4.88 2.83 0.76 05 Min 20.17 2.93 19.90 3.74 0.76
Weight (Kg) 17.62 6.00 19.33 5.84 0.27
10 Min 18.50 3.16 17.70 3.82 0.38
Sex (M/F) 18/13 21/9 0.5
15 Min 16.67 3.34 19.27 17.66 0.43
[Table/Fig-2]: Comparison of demographic variables.
Un-paired t test is applied. p-value is significant if <0.05 20 Min 16.00 3.83 15.37 4.27 0.55
Haemangioma-thorax abdomen 0 1 1
Adequate sedation, as defined by obtaining a Ramsay Sedation
Hemiplagia 0 1 1 Score of 6, was attained in all the patients in both the study groups.
Hydrocephalus 1 0 1 There were no cases of sedation failure or requirement for rescue
Impaired hearing 1 1 2 sedation in any of the study subjects.
Meduloblastoma 1 2 3 Group K (n=31) Group D (n=30)
Significance
Meningomyocoele 1 1 2
Parameter Time points Mean SD Mean SD (p-value)
Obstructive jaundice 1 0 1
Saturation 00-05 Min 99.10 0.88 98.83 1.02 0.28
Ophthalmic neuritis 1 1 2
00 Min 98.67 1.03 98.57 1.10 0.72
Post meningitis sequlae 0 1 1
05 Min 94.33 16.23 94.00 16.21 0.94
Precocious puberty 1 0 1
10 Min 93.07 16.77 93.00 16.79 0.99
Seizure disorder 5 5 10
15 Min 95.57 1.59 95.40 1.81 0.71
Short stature, failure to thrive 2 1 3
20 Min 95.20 1.81 95.10 1.77 0.83
Spontaneous pneumthorax 1 0 1
25 Min 95.17 1.95 95.37 2.06 0.70
Undescended testis 1 1 2
30 Min 94.87 1.98 95.00 2.15 0.80
Grand total 31 30 61
35 Min 95.47 1.78 95.63 1.99 0.73
[Table/Fig-3]: Comparison of diagnosis between Group K and Group D.
Un-paired t test is applied. p-value is significant if <0.05 40 Min 95.47 1.89 95.43 1.81 0.94
45 Min 95.47 1.91 95.27 1.93 0.69
Event of adverse reaction like desaturation and apnoea was not
50 Min 94.80 1.65 95.17 1.95 0.43
observed in any patient in either group. The saturation level from
0-60 minutes in both the groups, recorded at every 05 minutes 55 Min 95.97 1.54 96.17 1.60 0.62
interval, showed no statistically significant differences [Table/Fig-5]. 60 Min 96.40 1.50 96.70 1.29 0.41
00-60 Min Significance
Group K (n=31) Group D (n=30) Group K (n=31) Group D (n=30)
Significance Events of (recorded (p-value)
Parameter Time points Mean SD Mean SD (p-value) Apnoea at every 05
min interval ) NIL NIL 1.00
minus 05
[Table/Fig-5]: Comparison of saturation and events of apnoea between Group K
Min 107.10 10.41 105.10 9.89 0.45
and Group D.
00 Min 114.63 10.74 112.86 12.10 0.55 *Un-paired t-test is applied. p-value is significant if <0.05
05 Min 106.10 8.55 104.87 9.41 0.60 All the patients completed their MRI scan without any interruption.
10 Min 103.30 7.63 101.67 9.26 0.46 However, the onset of sedation (Mean±SD) in Group K was
6.30±1.32 minutes and 12.20±SD=2.01 minutes in Group D
15 Min 101.53 8.92 99.10 8.37 0.28
(p=0.001). The time to Modified Aldrete Score of 10/10 was
20 Min 99.07 7.63 95.77 9.68 0.15 higher in Group K. (Mean±SD; 21.10±1.84 minutes in Group K vs
Heart rate 25 Min 98.03 6.54 95.30 8.98 0.18 13.73±1.89 minutes in Group D [Table/Fig-6]. This difference in
(b/min) between the groups was statistically significant (p=0.001).
30 Min 98.43 7.33 96.03 9.33 0.27
Time To Aldrete Score 10/10 (in min) 21.10 1.84 13.73 1.89 0.001
55 Min 99.57 8.40 97.60 9.39 0.40
[Table/Fig-6]: Comparison of induction and recovery between Group K and Group D.
60 Min 99.70 7.56 98.40 9.64 0.56 Un-paired t test is applied. p-value is significant if <0.05
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PARTICULARS OF CONTRIBUTORS:
1. Reader, Department of Anaesthesiology and Critical Care, AFMC, Pune, Maharastra, India.
2. Assistant Professor, Department of Anaesthesiology and Critical Care, AFMC, Pune, Maharastra, India.
3. Assistant Professor, Department of Anaesthesiology and Critical Care, INHS, Ashwini, Mumbai, Maharastra, India.
4. Reader, Department of Anaesthesiology and Critical Care, AFMC, Pune, Maharastra, India.
5. Resident, Department of Anaesthesiology and Critical Care, AFMC, Pune, Maharastra, India.
6. Resident, Department of Anaesthesiology and Critical Care, AFMC, Pune, Maharastra, India.
NAME, ADDRESS, E-MAIL ID OF THE CORRESPONDING AUTHOR: PLAGIARISM CHECKING METHODS: [Jain H et al.] Etymology: Author Origin
Alok Jaiswal, • Plagiarism X-checker: May 23, 2020
402, Shellar Heights, Wanowarie, Pune, Maharastra, India. • Manual Googling: Jul 24, 2020
E-mail: [email protected] • iThenticate Software: Oct 10, 2020 (22%)
Author declaration:
• Financial or Other Competing Interests: None Date of Submission: May 22, 2020
• Was Ethics Committee Approval obtained for this study? Yes Date of Peer Review: Jun 27, 2020
• Was informed consent obtained from the subjects involved in the study? Yes, (from guardians) Date of Acceptance: Jul 29, 2020
• For any images presented appropriate consent has been obtained from the subjects. NA Date of Publishing: Nov 01, 2020